What is a Command-Line Interface? 🔗
A command-line interface (CLI) is software you start with a single shell command (or an automated script). There is no on-screen menu, button, or image viewer. Input files drop into a watched folder or API endpoint; output files—PDF, JSON, DICOM SR, or annotated images—land in another folder or are pushed to the hospital’s PACS. For clinicians the interaction happens somewhere else (their familiar PACS, ECG viewer, or EHR). To them the AI engine is invisible, yet the workflow feels unchanged. OsteoDetect, for example, simply returns an annotated DICOM that radiologists open in the PACS they already use.
Why a CLI Is Simpler to FDA Clear
| Regulatory task | GUI-based app | CLI / headless service |
| UI hazard analysis | Must map every screen, button, color, alert | Nearly none—only file paths / API calls |
| Human factors data in 510(k) | Often expected | Usually “not applicable” |
| Software description | Multiple user stories | One diagram: input → algorithm → output |
| Verification & validation | Functional + UI tests | Functional tests only |
| Labeling | Full user manual | One-page “installation & integration guide” |
The CLI shifts risk-control for display, navigation, and confirmation steps to another device that is already cleared for those tasks. FDA reviewers therefore spend less time on UI traceability and more on the algorithm’s clinical performance—usually the sponsor’s strong suit.
Why Human-Factors / Usability Testing Often Falls Away
FDA’s 2016 Human-Factors Guidance scopes testing to the user interface—“all points of interaction between user and device.” If the AI module never presents controls or data directly to the user, those points sit in the hosting PACS or viewer, not in the AI software. Sponsors still document that decision, but they may cite the guidance and state that only installation personnel interact with the CLI, so conventional summative usability testing is unwarranted. U.S. Food and Drug Administration
Caveat: you must confirm the host system’s UI and the combined workflow do not introduce new use-related hazards. If they do, the burden shifts back to you.
Why AI Algorithms Fit This Strategy
- Automated by nature. Most AI in imaging or signal analysis can run fully unattended once images arrive.
- Output is data, not interaction. The deliverable (bounding box, contour, risk score) is easily serialized into DICOM, JSON, or a worklist flag.
- Compute lives on a server. The same box that hosts the model can expose a one-line CLI or REST endpoint; no need to port a full GUI across Windows, macOS, and Linux.
- Clinical trust resides in existing viewers. Radiologists, cardiologists, and pathologists stay inside the workstation they trust, reducing training time and accelerating adoption.
Dozens of devices already use this pattern—from Imagen’s OsteoDetect to Paige Prostate, Fibresolve, SubtlePET, and many others in the 2023-2025 clearance list—demonstrating that FDA is comfortable reviewing AI modules that live “behind the curtain.” FDA Access Data
Examples 🔗
The following table was generated by an internal AI agent we use to conduct exhaustive searches of the FDA database that will soon be available for anyone to use.
| KNUMBER | APPLICANT | DEVICENAME | Is Command Line Only? |
| DEN180005 | Imagen Technologies, Inc. | OsteoDetect | The summary states, "The end user interacts with the output of OsteoDetect in the facility's PACS software" and describes the output as annotated DICOM images sent back to the DICOM storage server/PACS, indicating no separate GUI for OsteoDetect itself. |
| DEN200080 | Paige.AI | Paige Prostate | The summary repeatedly states that Paige Prostate's outputs (coordinates, classification) are displayed within or overlaid onto a separate viewing software (Paige FullFocus), and the pathologist interacts with these results via that viewer, implying Paige Prostate itself does not have a direct graphical user interface for the end-user. |
| DEN220040 | Imvaria, Inc | Fibresolve | The 'DEVICE DESCRIPTION' section states the system consists of APIs for input and output, outputs a report, and explicitly mentions, "The system does not include an image viewer or produce visual output for diagnostic use." and "Fibresolve does not provide any visual aid to the clinician to assist in interpreting the image." |
| DEN210015 | Sunrise | Sunrise Sleep Disorder Diagnostic Aid | The summary describes a cloud-based software component and a mobile application that is not used by healthcare providers to interpret the results. |
| K142693 | Zywie, Inc. | ZywieAI Software Library | The summary describes the software as an "object library" accessed via an "Application Program Interface (API)" or "web service call", which is integrated into other applications and outputs data to a file, strongly implying it lacks its own GUI. |
| K173780 | Bay Labs, Inc. | EchoMD Automated Ejection Fraction Software | The summary explicitly states, "EchoMD AutoEF operates as a microservice background function communicating with ultrasound systems and PACS workstation systems, which provide the user interface." |
| K181572 | Mirada Medical Ltd. | Workflow Box | The summary explicitly states on page 5: "Once data is routed to the auto contouring workflows there is no user interaction required and no user interface for visualizing image data." It also states in the comparison table on page 6 under "Design: Data Visualisation/Graphical User Interface" for Workflow Box: "None – the proposed device has no data visualization functionality." |
| K181823 | AliveCor, Inc. | KardiaAI | The summary describes KardiaAI as a "software analysis library" and an "Application Program Interface (API) library" that is "intended to be integrated into other device software" and sends "algorithm output for display" via the API, strongly indicating it lacks its own user interface. |
| K182177 | MaxQ-Al Ltd. | Accipiolx | The summary states the output is made available to a PACS/workstation for worklist prioritization and explicitly notes "No" for "Non-Diagnostic Preview", implying it does not have its own user interface for viewing results directly within the software. |
| K182336 | Subtle Medical, Inc. | SubtlePET | The comparison table on page 5 explicitly states "None" under the "User Interface" row for the Subject Device (SubtlePET) and adds that "enhanced images are viewed on existing PACS workstations". |
| K183182 | GE Medical Systems, LLC. | Critical Care Suite | The summary describes the software as analyzing images and enabling case prioritization by flagging images or sending notifications *within* the PACS/workstation or directly on the X-ray system for technologists, rather than having its own distinct user interface for radiologists/technologists to interact with for the primary task. |
| K183285 | CureMetrix, Inc | cmTriage | The summary states the software analyzes images in the cloud, produces a DICOM Structured Report (SR) file, sends this file back to the PACS, and the PACS extracts the code to update its own worklist. This indicates the interaction happens via the PACS interface using the exported report, not a dedicated GUI for cmTriage itself. |
| K190362 | Zebra Medical Vision Ltd. | HealthPNX | The summary states the software "makes case-level output available to a PACS/workstation for worklist prioritization or triage", "doesn't output an image", and does not "mark, highlight, or direct users' attention to a specific location on the original chest X ray", indicating it sends results to another system rather than having its own GUI for user interaction with the image or results. |
| K190424 | Zebra Medical Vision Ltd. | HealthICH | The summary explicitly states on page 4, under the "IMA Integration feature" section: "It does not have a Graphical User Interface (GUI)." |
| K191278 | MultiModal Imaging Services Corporation (dba HealthLytix) | RSI-MRI+ | The summary explicitly states under the "Differences" between the subject and predicate devices: "Image viewing (RSI-MRI+ does not contain this functionality, images are viewable on most 3ª party commercial PACS workstation software)". |
| K191688 | Subtle Medical, Inc. | SubtleMR | The summary explicitly states in Section 5.1 "the device has no user interface" and repeats this in Table 5-2 under "User Interface" for the Subject Device ("None - enhanced images are viewed on existing PACS workstations"). |
| K192004 | Eko Devices Inc | Eko Analysis Software | The summary explicitly states in the comparison table that the software's interface is an "Application programming interface (API)" and under "Display" it says "No primary display". It also mentions results are returned "through an interface to the mobile apps for display". |
| K192051 | CorticoMetrics LLC | THINQ | The summary explicitly describes the software as "non-interactive" and details its function as accepting MRI data as input and producing reports (PDF, DICOM-JPEG overlays) as output, implying automated processing without a direct user interface for operation. |
| K192109 | IB Lab GmbH | KOALA | The summary states, "Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation," indicating the results are exported for viewing in other software, not within KOALA itself. It also describes KOALA operating in a Linux environment requiring an integration environment for input/output, typical of headless server software. |
| K192167 | CuraCloud Corp. | CuraRad-ICH | The summary describes the software as integrating with a third-party worklist/PACS/workstation to receive requests and return findings, and explicitly states "Non-Diagnostic Preview: No", implying it operates without its own user interface for direct interaction or image review. |
| K192880 | Beijing Infervision Technology Co.,Ltd. | InferRead Lung CT.AI | The summary states, "Users are an existing PACS system to view the annotations," indicating the output is viewed in separate software, not within a GUI provided by InferRead Lung CT.AI itself. |
| K193229 | ScreenPoint Medical B.V. | Transpara | The summary states on page 5: "Results of Transpara™ are computed in processing server... and sends the processing output to a destination using the DICOM protocol... Implementation of a user interface for end users in a medical workstation is to be provided by third parties." This indicates the core software is a server process without its own end-user GUI. |
| K193252 | MIM Software Inc. | Contour ProtegeAI | The summary repeatedly states that Contour ProtégéAI is an accessory to MIM software and that MIM software *must* be used to review and edit the contours generated by Contour ProtégéAI, indicating Contour ProtégéAI itself does not have a user interface for these functions. |
| K193300 | RADLogics, Inc. | AIMI-Triage CXR PTX | The summary states, "The user interface is minimal, consisting of the radiologist's existing picture archiving and communication system (PACS) viewer and worklist in which positively identified images are flagged by the software". This indicates the software integrates with an existing interface (PACS) rather than having its own distinct GUI. |
| K200750 | TeraRecon, Inc. | Neuro.Al Algorithm | The summary states that the results "can be delivered to the end-user through image viewers such as TeraRecon's Aquarius iNtuition system... or other image viewing systems like PACS" and explicitly mentions "the only interface is through DICOM", indicating the software itself lacks a GUI and outputs results for other systems to display. |
| K200884 | B-Secur Ltd. | B-Secur HeartKey Software Library | The summary describes the software as an "object library", a "collection of callable functions", states that "All features are accessed via an application programming interface (API)", and that it is "intended to be integrated into other device software", strongly indicating it lacks its own user interface for end-use. |
| K200921 | Qure.ai Technologies | qER | The summary states the software analyzes images and sends notifications/flags and non-diagnostic preview images to existing systems (PACS, worklist), implying it integrates with them rather than having its own primary user interface for viewing results. It also explicitly mentions it does not alter or mark the original images. |
| K201039 | Resonance Health Analysis Services Pty Ltd | HepaFat-AI | The summary states "No user input is required for the analysis" for HepaFat-AI, contrasting it with the predicate device (HepaFat-Scan) which required human interaction for ROI selection and included visualization tools. The output is described as an automated report. |
| K201232 | Limbus AI Inc. | Limbus Contour | The summary states that "Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations," and later repeats that it "does not contain an image viewer." This indicates it lacks its own visual user interface for these core functions. |
| K201476 | DreaMed Diabetes Ltd | DreaMed Advisor Pro | The device description states results are "sent to a qualified Diabetes Management Systems, which displays results to physicians and a report provided by DreaMed Diabetes", implying Advisor Pro itself does not have the primary display interface but relies on the DMS and an exported report. |
| K201560 | Samsung Electronics Co.,Ltd. | Auto Lung Nodule Detection | The summary states the software "sends information of suspected nodules to the visualization part of S-Station... to generate output images with circular marks" and that "The CAD performed images, are displayed on the screen by S-Station". This indicates the detection software itself does not have the visualization GUI; it processes data and sends results to another system (S-Station) for display. The comparison table also notes its output is "Information for ROI to be marked", unlike the predicate which outputs the marked image directly. |
| K201985 | AliveCor, Inc. | KardiaAI | The summary describes KardiaAI as a "software analysis library" and an "API library" intended to be "integrated into other device software," stating that "Recording and viewing of ECGs and the results of the KardiaAI analyses are to be provided by other AliveCor FDA-cleared devices... into which the API library is incorporated." This indicates it lacks its own user interface for displaying results. |
| K202013 | Whiterabbit.ai Inc. | WRDensity by Whiterabbit.ai | The summary describes the software as taking input via DICOM transfer, automatically analyzing images, and sending outputs (DICOM Secondary Capture, Structured Report, text labels) to be stored and reviewed on other systems like PACS, RIS, and mammography workstations. This implies it operates as a background process without its own interactive GUI for the end-user radiologist. |
| K202404 | MRIguidance B.V | BoneMRI | The comparison table in Section VI.B explicitly states "None" for the "User Interface" characteristic of the BoneMRI software, adding that "enhanced images are viewed on existing PACS workstations". |
| K202414 | Hyperfine Research, Inc | BrainInsight | The comparison table on page 4, under "User Interface / Physical Characteristics", states for BrainInsight: "• No software required", "• Operates in a serverless cloud environment", and "• User interface through PACS (multiple vendors)". This contrasts with the predicate device which has a "User interface through the software package", indicating BrainInsight itself lacks a direct user interface and interaction occurs via PACS. |
| K202487 | Zebra Medical Vision Ltd. | HealthJOINT | The device description explicitly states, "The software communicates with the API only, and is not user-facing." and "The result is made available via a 3rd parties' software interface for further display and analysis...". |
| K202700 | TheraPanacea | ART-Plan | The summary explicitly states the software has a graphical interface ("Data Visualization / Graphical Interface: ") and describes user interactions like displaying, visualizing, editing contours, and accessing it via a web browser, all of which require a GUI. It contrasts this with another predicate device (Workflow Box) which is described as having no data visualization functionality. |
| K202928 | Deepvoxel INC | DV. Target | The summary explicitly states multiple times that the software lacks a user interface for data visualization (e.g., in sections {2}, {4}, {6}, {7}, and {8}), mentioning that results are managed via an administration interface and must be reviewed/edited in separate software. |
| K202990 | Nines, Inc. | NinesMeasure | The device description states it "operates over a standard network interface", "receives... images and coordinates", "returns the measurements", and is "designed to be used with a standard PACS, where the user can... review and edit the measurements on the DICOM image". This implies the core software processes data and returns it, with the user interaction happening via the separate PACS system. |
| K203182 | Subtle Medical, Inc. | SubtleMR | The summary explicitly states "the device has no user interface" in the Device Description section (page 4) and lists "None" under the "User Interface" category in the comparison table (page 5). |
| K203235 | Vysioneer Inc. | VBrain | The summary states that medical professionals must finalize the contours "using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system," indicating VBrain itself does not provide this interface and exports its results. |
| K203256 | Imbio, LLC | Imbio RV/LV Software | The summary explicitly states the software is a "single command-line executable program" with a "minimal" user interface, and the comparison table lists its interface as "Command-Line" in contrast to the predicate device's "Graphical user interface". |
| K203258 | Siemens Healthcare GmbH | syngo.CT Lung CAD | The text explicitly states in the Indications for Use section (pages 2, 6, and 8) that "The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface." |
| K203260 | Siemens Medical Solutions USA, Inc. | syngo.CT Brain Hemorrhage | The summary states the software "makes case-level output available to a CT scanner or other PACS system for worklist prioritization" and is a "notification-only, parallel workflow tool", indicating it sends results elsewhere rather than having its own diagnostic user interface. |
| K203517 | DeepHealth, Inc. | Saige-Q | The summary states the software runs on a server, receives DICOM files, processes them, generates a code, and sends the output (code and optional preview image) to other clinical IT systems (PACS/EPR/RIS/workstation) where it is viewed by the user within the worklist of those systems. This implies Saige-Q itself does not have a direct user interface for the radiologist's primary interaction (viewing the prioritization code). |
| K203610 | Quantitative Radiology Solutions, LLC | Automatic Anatomy Recognition (AAR) | The summary states that the software "relies on third party treatment planning systems to display and edit the contours" and "does not provide the capability to modify contours. If adjustments are required, they must be performed on another system." This indicates the AAR software itself lacks a user interface for these core functions. |
| K210404 | ScreenPoint Medical B.V. | Transpara 1.7.0 | The summary states: "Implementation of a user interface for end users in a medical workstation is to be provided by third parties." This indicates the core Transpara software itself does not have the end-user GUI. |
| K210543 | Implicity, Inc. | IM007 | The summary explicitly states in Table 4 (page 13) under the feature "User interface to view ECG data with tools" that the Subject Device IM007 response is "No. IM007 does not include a user interface for viewing ECG data, as the viewing of ECG data belongs to the 'client' application." It also describes IM007 as a "server-side service" accessed via an API, receiving data from and sending analysis results to a separate "remote monitoring platform" or "client application" (pages 13, 14, 15). |
| K210719 | Change Healthcare Canada Company | Change Healthcare Anatomical AI | The summary states the software "communicates via Application Programmable Interfaces (APIs) which allow for receiving DICOM images and returning inference results" and "produces a JSON file which contains results", exporting these to "integrated healthcare systems". This describes an API-driven backend process without mentioning any direct user interface component for the software itself. |
| K210822 | Medicalgorithmics S.A. | DeepRhythmAI | The summary explicitly states on page 4, "DeepRhythmAl doesn't have a User Interface therefore it should be integrated with the external visualization software...". It is also listed in the comparison table on page 6 under "Display or Graphical User Interface (GUI)" as having "No primary display or GUI", and reiterated in the differences summary on page 10. |
| K210831 | CorTechs Labs, Inc | OnQ Neuro | The summary explicitly states in Section 4 (Device Description) that "The software is designed without the need for a user interface after installation" and in Section 7 (Comparison to Predicate Device) that "OnQ Neuro does not include a GUI". |
| K211222 | Qure.ai Technologies | qER-Quant | The summary describes the software interacting directly with PACS systems to receive scans and return results (PDF reports, DICOM overlays) to PACS or other specified systems, implying it runs as a background process without its own interactive GUI. |
| K211733 | Lunit Inc. | Lunit INSIGHT CXR Triage | The summary describes the software as providing "case-level output available in the PACS/workstation for worklist prioritization or triage", integrating with existing systems, and sending "passive notification" rather than having its own interactive interface for the interpreting specialist. |
| K211788 | Nico.Lab B.V. | HALO | The summary describes the software as "notification only" and states that after analysis, it "sends a notification" and provides a "link to DICOM Web viewer allowing users review the images," implying the review happens in a separate viewer, not within a GUI provided by the HALO software itself. |
| K211841 | Spectronic Medical AB | MRI Planner | The summary states, "MRI Planner does not display or store DICOM images. The user is advised to use existing softwares for radiotherapy treatment planning to display and modify generated images and contours." This indicates the software lacks its own interface for viewing or interacting with the images/contours it produces. |
| K211964 | Subtle Medical, Inc. | SubtlePET | The summary includes a table (Table 3) comparing technological characteristics, which explicitly lists "None" for the "User Interface" characteristic of the software. |
| K212116 | Vysioneer Inc. | VBrain-OAR | The summary states that users "must finalize (confirm or modify) the contours generated by VBrain-OAR, as necessary, using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system." It also describes the workflow management module as interacting with PACS and exporting DICOM output, implying it operates as a backend process without its own viewing/editing interface. |
| K212218 | Elekta Solutions AB | Advanced Algorithms for Treatment Management Applications (AATMA) | The summary explicitly states multiple times (e.g., in the Indications for Use, Device Description, and Comparison Table) that "AATMA™ does not provide a user interface" and is "designed to be accessed through its application programming interface (API)". |
| K212365 | Gleamer | BoneView | The summary describes BoneView receiving images from a DICOM Source, processing them, and sending result files (annotated images, summary table) in DICOM format to a DICOM Destination (like PACS or X-ray systems) where they are visualized by the user. It explicitly states "Image Viewing" occurs in the "PACS system", indicating BoneView itself does not provide the primary viewing interface. |
| K212466 | DiA Imaging Analysis Ltd | LVivo Seamless | The summary describes the software as a "standalone application that extends the LVivo Platform and runs offline on a server", automatically processing DICOM files and sending the results "to the PACS" where they are "evaluated by a healthcare professional", implying it operates without its own interactive GUI for end-user evaluation. |
| K212662 | AliveCor, Inc. | AliveCor QT Service | The summary describes the software as a cloud-based service accessed by other medical software systems via a "REST-based application program interface (API)", receiving ECG data and responding with measurements via this API. It does not mention any direct user interface or GUI for the service itself. |
| K212783 | ScanMed, LLC | ProstatID | The comparison table (Table 1 on page 7) explicitly states that ProstatID "does not include a standalone graphical user interface" and that its outputs are in DICOM format to be viewed on separate DICOM-compliant image viewers. |
| K212915 | MVision AI | MVision AI Segmentation | The summary explicitly states that the produced segmentation templates "must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve", indicating the software itself does not provide this interface and exports its output. |
| K213253 | Pixyl SA | Pixyl.Neuro | The summary describes the software as "Cloud-based software launchable through Picture Archive and Communications Systems (PACS)" and states its output "Supports DICOM format as output of results that can be displayed on DICOM workstations and Picture Archive and Communications Systems". This implies interaction happens via PACS integration and results are viewed on separate systems, not within a dedicated GUI for the Pixyl.Neuro software itself. |
| K213566 | Riverain Technologies, Inc. | ClearRead Xray Pneumothorax | The summary describes the software as receiving images via DICOM, processing them, and delivering results via DICOM to a PACS/workstation for worklist prioritization or triage, operating passively and in parallel to standard workflow, without mentioning any direct user interface on the device itself for result viewing. |
| K213794 | Eko Devices, Inc. | Eko Murmur Analysis Software (EMAS) | The summary states the software is a cloud service accessed via an API, outputs results as a JSON file to a requesting application for display, and the comparison table explicitly lists the interface as an API and the display as "No primary display". |
| K213795 | VideaHealth, Inc | Videa Caries Assist | The device description states it is "available as a service via an API" and is "accessed by the dental practitioner through their Dental Viewer", indicating the core software operates via API and relies on a separate viewer application for user interaction and display of results (bounding boxes). |
| K213941 | Annalise-AI | Annalise Enterprise CXR Triage Pneumothorax | The summary describes the software as interfacing with RIS and PACS, processing images, and sending its output (AI results) *to* the reporting worklist software (RIS, PACS) to enable triage/prioritization within *that* software's worklist. It doesn't mention a user interface for the Annalise software itself, implying it operates in the background (headless) and communicates its findings to other systems. |
| K213976 | MIM Software Inc. | Contour ProtégéAI | The summary repeatedly states that "Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI," implying Contour ProtégéAI itself does not provide this visualization/editing interface. It is also described as an "accessory" performing "automated processing". |
| K220080 | MedCognetics, Inc. | CogNet QmTRIAGE | The summary describes the software as a "passive notification-only, parallel-workflow software tool" that "produces an exam level output to a PACS/Workstation for flagging the suspicious study and allows for worklist prioritization". It also mentions an "Encapsulated PDF stored with original DICOM study". This indicates the software sends results *to* another system (PACS/Workstation) rather than having its own interactive user interface for the physician. |
| K220105 | DeepHealth, Inc. | Saige-Dx | The device description states that Saige-Dx outputs results as DICOM Structured Report (SR) and Secondary Capture (SC) objects, which are then used by a separate "viewing workstation" to display markings overlaid on images, indicating Saige-Dx itself does not have the primary viewing GUI. |
| K220164 | AZmed SAS | Rayvolve | The summary states Rayvolve is "intended to work in combination with Picture Archiving and communication system (PACS) servers" and that for "Image Viewing", the "PACS system" is used, with "image annotations made on a copy of the original image", implying the results are viewed within the PACS interface, not a dedicated Rayvolve GUI. |
| K220264 | Ever Fortune.AI Co., Ltd. | EFAI RTSuite CT HN-Segmentation System | The text explicitly states on page 4, "The device does not offer a user interface..." and "...no user interaction is required, nor provided." The comparison table on page 5 also lists "No" under the "User Interface" row for the EFAI HNSeg device. |
| K220349 | TeraRecon, Inc | TeraRecon Neuro | The summary states the software is a "standalone image processing software device" deployed as an executable or container, and its results "can be delivered to the end-user through image viewers such as TeraRecon's Aquarius Intuition system... or other image viewing systems like PACS". This indicates the software itself processes data and outputs results, but relies on separate viewing systems for user interaction with those results, implying it lacks its own GUI. |
| K220624 | AI4MedImaging Medical Solutions S.A. | AI4CMR v1.0 | The summary explicitly states that the user interface is provided by a third-party DICOM viewer application and that the user incorporating AI4CMR is responsible for implementing it. It describes AI4CMR as a cloud-hosted service and a plug-in, indicating it doesn't have its own GUI. |
| K220766 | CSD Labs GmbH | eMurmur Heart AI | The summary explicitly states in the comparison table (page 5) under "User Interface" for eMurmur Heart AI: "The user interface is not a part of eMurmur Heart Al (medical device); the user interface is part of 'eMurmur', a non-medical device." |
| K220815 | Hyperfine, Inc. | BrainInsight | The summary explicitly states under "User Interface / Physical Characteristics" that the "User interface [is] through PACS (multiple vendors)", indicating the software itself does not have its own GUI and relies on external systems to display results. |
| K221347 | ScreenPoint Medical B.V. | Transpara 1.7.2 | The summary states in section 4: "Results of Transpara® are computed in processing server... sends the processing output to a destination using the DICOM protocol... Implementation of a user interface for end users in a medical workstation is to be provided by third parties." This indicates the core software runs as a server and relies on other software for the user interface. |
| K221552 | Ever Fortune AI Co., Ltd. | EFAI ChestSuite XR Pneumothorax Assessment System | The summary describes the software as running on a server, analyzing images automatically, and sending notification messages or case-level output to a PACS/workstation for prioritization/triage, explicitly stating it does not mark or highlight images for the user, implying interaction occurs via the PACS/workstation rather than a dedicated GUI for this specific software. |
| K221762 | MRlguidance B.V. | BoneMRI v1.4 | The comparison table under "Technological Characteristics" explicitly states "User Interface: None - enhanced images are viewed on existing PACS". |
| K222070 | Therenva SAS | EndoNaut | The comparison table on page 6 explicitly states for the EndoNaut (Server) SW variant: "EndoNaut Server does not have a user interface. The User interface is provided by the clients. External interface with clients is provided through a communication protocol." |
| K222076 | Ever Fortune.AI Co., Ltd. | EFAI ChestSuite XR Pleural Effusion Assessment System | The summary describes the software running on a server, processing images, generating a JSON message output, and transferring it to an API server or PACS/workstation for worklist prioritization/triage. It explicitly states it does not mark or highlight images, indicating interaction happens via the receiving system, not a dedicated GUI for this software. |
| K222176 | Gleamer | BoneView | The summary describes the software receiving images from a DICOM source, automatically processing them, generating result files (images with annotations, summary table) in DICOM format, and sending these files to a DICOM Destination (like PACS) which is then used for visualization. This workflow implies BoneView itself does not have a direct user interface for interaction or viewing. |
| K222268 | Annalise-AI Pty Ltd | Annalise Enterprise CXR Triage Trauma | The summary describes the software as interfacing with PACS/RIS systems, analyzing images, and then providing "case-level output" or a "notification" back to the PACS/RIS for "worklist prioritization or triage", implying it operates in the background and integrates with existing systems rather than presenting its own user interface for this function. |
| K222275 | DeepHealth, Inc. | Saige-Density | The device description states that the software outputs DICOM files (a structured report and a secondary capture report) which "may be viewed on a mammography viewing workstation", implying the core software itself does not have its own user interface for viewing results. |
| K222463 | Ultromics Limited | EchoGo Heart Failure | The summary explicitly states on page 4, under Device Description: "EchoGo Heart Failure 1.0 is fully automated and does not comprise a user interface." |
| K222884 | iSchemaView, Inc. | Rapid NCCT Stroke | The summary describes the software running on a server ("Rapid server on premise or in the cloud") and sending notifications with preview images to users via external systems ("via PACS, email or mobile device"), explicitly stating these previews are not for diagnostic use beyond notification. This implies a lack of a direct interactive GUI for analysis. |
| K223240 | Annalise-AI Pty Ltd | Annalise Enterprise CTB Triage Trauma | The summary describes the software as interfacing with image and order management systems (like PACS/RIS), analyzing studies, and making "study-level output available to an order and imaging management system for worklist prioritization or triage". It also states the device is "not intended to direct attention to specific portions of an image", implying it doesn't have its own image viewing interface, but rather sends notifications to other systems. |
| K223268 | Hyperfine, Inc. | BrainInsight | The summary states under "User Interface / Physical Characteristics" that there is "No software required" and the "User interface [is] through PACS (multiple vendors)", indicating the software itself does not have a GUI and interaction/viewing occurs via PACS. |
| K223296 | VideaHealth, Inc. | Videa Perio Assist | The device description explicitly states, "The device itself is available as an API (Application Programming Interface)... Videa Perio Assist is accessed by the trained professional through their image viewer." This indicates it lacks its own GUI and integrates with other software via an API. |
| K223396 | iSchema View Inc. | Rapid RV/LV | The comparison table on page 5 explicitly lists the "Interface" type for the Rapid RV/LV software as "Command Line". |
| K223424 | GE Medical Systems SCS | Spine Auto Views | The summary explicitly states in the Device Description section (page 4) that the software generates reformats "without the need for a user interface and human interaction" and "no manual interaction required". Additionally, the comparison table (page 5) notes under "Measurement Tool" that the "Subject device doesn't have a user interface". |
| K223502 | Olea Medical | MR Diffusion Perfusion Mismatch V1.0 | The summary explicitly states on page 4, under "MR Diffusion Perfusion Mismatch V1.0 interaction with the technical platform", that the technical platform allows the docker (the software) to "...visualize the outputs as the docker has no interface." It also contrasts it with the predicate device on page 5, noting the predicate "is equipped with a visualization interface, whereas MR Diffusion Perfusion Mismatch V1.0 needs to communicate with the technical platform to visualize the outputs." |
| K223623 | Subtle Medical Inc. | SubtleMR (2.3.x) | The summary explicitly states in the "Device Description Summary" section: "As it only processes images for the end user, the device has no user interface." |
| K223646 | IB Lab GmbH | IB Lab LAMA | The summary states, "The user does not interact directly with IB Lab LAMA except or reject the generated report findings via cleared third party medical viewers," indicating the software itself lacks a direct user interface for interaction. |
| K223754 | Bering Ltd | BraveCX | The summary states BraveCX is supplied as a licensed Application Programming Interface (API) and that its results are made available via DICOM or JSON files, displayed through the worklist interface of external systems like PACS/workstation, implying it doesn't have its own GUI. |
| K223774 | MIM Software Inc. | Contour ProtégéAI | The summary states Contour ProtégéAI is an "accessory to MIM software" and that "Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI", indicating it relies on another program (MIM software) for user interaction with its output. |
| K230082 | GE Medical Systems, LLC | Auto Segmentation | The comparison table on page 5 explicitly states under "User Interface" for the proposed device: "Automated execution of the software with no user interaction, other than configuration settings. Generated contours are automatically transmitted to review workstation(s) supporting RTSS objects for review and editing, as needed." |
| K230085 | Imagen Technologies, Inc | Lung-CAD | The summary states the output is a "DICOM Presentation State file (output overlay)" which "can be toggled on or off by the physician within their Picture Archiving and Communication System (PACS) viewer". This indicates the software generates an output file viewed in separate software (PACS), not through its own GUI. |
| K230112 | Imbio, Inc. | CAC Software | The summary explicitly states on page 4, section 1.7: "The Imbio CAC Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal." It also describes the output as DICOM files and PDF reports written to a directory. |
| K230197 | MRIguidance B.V. | BoneMRI v1.6 | The summary explicitly states under the "Technological Characteristics" comparison table, in the row labeled "User Interface", that it has "None - enhanced images are viewed on existing PACS workstations". It also describes the software as a "server application" whose output images are returned to a DICOM archive (like PACS) for viewing using separate software. |
| K230264 | Ezra AI, Inc. | Ezra Flash | The summary explicitly states in the Device Description section "the device has no interface" and repeats in the comparison table under "User Interface" that it has "None - enhanced images are viewed on existing PACS workstations". |
| K230534 | Aidoc Medical, Ltd. | BriefCase-Quantification | The summary states the software runs on a server, processes images, and then the output/results are "transferred to an image review software (desktop application), and forwarded to user review in the PACS" or "exported in DICOM format, and are sent to a PACS destination for review". This implies the core software itself does not have a direct user interface for review, relying on other systems to display its output. |
| K230552 | Olea Medical | MR DWI/FLAIR Measurement V1.0 | The summary explicitly states as a difference from the predicate device: "Olea Sphere V3.0 is equipped with a visualization interface whereas MR DWI/FLAIR Measurement V1.0 needs to communicate with the technical platform to visualize the outputs." |
| K230575 | Limbus AI Inc. | Limbus Contour | The summary states in the Device Description section: "Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations." and that it interfaces via "importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files". This indicates it lacks its own display GUI and operates by processing files for use in other systems. |
| K230850 | Enhatch, Inc. | United Orthopedic Knee Patient Specific Instrumentation | The summary explicitly states under technological differences: "Internal facing versus external user interface, United Orthopedic Knee Patient Specific Instrumentation software follows a SaaS preoperative planning workflow where Enhatch technicians interface directly with the software and provide end user outputs" and "does not allow end user to perform measurements in software but uses an optimization algorithm... approved by surgeon via a preoperative plan". This indicates the end-user surgeon does not directly use a GUI but interacts via technicians and an output plan. |
| K230899 | Qure.ai Technologies | qXR-PTX-PE | The summary states the software "provides case-level output available in the PACS/workstation for worklist prioritization or triage" and sends "passive notification" by flagging images within the PACS/workstation/DICOM viewer, rather than having its own direct user interface or sending proactive alerts directly to users. |
| K230913 | Imeka Solutions, Inc. | ANDI | The summary explicitly states in the comparative data section: "While the predicate features a user interface for planning and visualization, ANDI relies on an API for image input and report output." |
| K231010 | AliveCor, Inc. | Corvair | The summary states Corvair is provided as an "Application Program Interface (API) library" and that "Viewing of Corvair's ECG analysis is handled by the target device", indicating Corvair itself does not have a user interface for viewing. |
| K231025 | Ever Fortune.AI Co., Ltd. | EFAI NeuroSuite CT ICH Assessment System | The summary describes the software as making "case-level output available to a PACS/workstation for worklist prioritization or triage", providing a "passive notification through the PACS/workstation", and explicitly states it "does not mark, highlight, or direct users' attention to a specific location on the original non-contrast head CT". The comparison table also notes "Non-Diagnostic Preview: No". This indicates the software operates in the background and sends results to another system, lacking its own interactive graphical user interface for displaying analysis results. |
| K231068 | Holberg EEG AS | autoSCORE | The summary explicitly states in sections {3} and {6} under "Indications for Use": "autoSCORE does not have a user interface. autoSCORE sends this information to the EEG reviewing software...". |
| K231094 | Annalise-AI Pty Ltd | Annalise Enterprise CTB Triage-OH | The summary states the device "makes study-level output available to an order and imaging management system for worklist prioritization or triage" and contrasts it with a predicate device that directs output "to another desktop application," implying the subject device integrates directly into existing systems (like a worklist) rather than having its own user interface/application. |
| K231149 | Qure.ai Technologies | qXR-CTR | The summary describes the software as automatically analyzing images and outputting a structured report (in DICOM, JSON, or PDF format) which includes image previews and results, often sent back to PACS. It does not mention any interactive GUI for the user within the qXR-CTR software itself. |
| K231157 | Siemens Healthcare GmbH | syngo.CT Lung CAD (Version VD30) | The summary explicitly states in the Indications for Use section (repeated on pages 2, 5, and 7) that "The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface." |
| K231384 | Annalise-AI Pty Ltd. | Annalise Enterprise CTB Triage Trauma | The summary describes the software as interfacing with image and order management systems (like PACS/RIS), analyzing studies, and providing study-level output/notifications back to those systems for worklist prioritization or triage, without mentioning any direct user interface for the Annalise software itself. |
| K231459 | Resonance Health Analysis Services Pty Ltd | HepaFatSmart (V2.0.0) | The summary states the user uploads DICOM images via a portal (FAST), and "No other user input is required for the analysis". It also contrasts this with a predicate device (HepaFat-Scan) that required "human interaction for Region of Interest (ROI) selection". The output is described as automatically generated reports. This indicates the core software operates automatically without a direct user interface for the analysis process itself. |
| K231631 | Aidoc Medical, Ltd. | BriefCase-Quantification | The summary states the software runs on a server, receives scans, processes them, and then the "output of the algorithm analysis is transferred to an image review software (the PACS or a desktop application)" and results/reports are "exported... and are sent to a PACS destination for review". This indicates the core software doesn't have its own GUI for user review; interaction happens via data transfer to other systems. |
| K231765 | MIM Software Inc. | Contour ProtégéAI | The summary repeatedly states that Contour ProtégéAI is an "accessory to MIM software" and that "Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI", implying it does not have its own visualization GUI for these tasks. |
| K231767 | Annalise-AI Pty Ltd | Annalise Enterprise CTB Triage Trauma | The summary states the device "makes study-level output available to an order and imaging management system for worklist prioritization or triage" and "provides a notification to the image and order management system". This indicates it sends data to another system rather than having its own user interface for clinicians. |
| K231779 | Epitel, Inc. | REMI AI Discrete Detection Module | The summary states that the software "marks previously acquired sections of REMI EEG" and that the marked seizure activity is "to be viewed in an EEG viewing software", implying the subject software outputs annotations for use in another program rather than having its own viewing GUI. |
| K231805 | Qure.ai Technologies | qXR-LN | The summary states the software receives DICOM images, processes them, and "produces DICOM format outputs that enable users to view the presence and location of lung nodules" and is designed "to be used with any DICOM viewer or PACS", implying it outputs results for viewing in other systems rather than having its own viewing interface. |
| K231855 | Quanta Computer Inc. | QOCA® image Smart RT Contouring System | The summary explicitly states on pages 2, 5, and 6: "QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface." It also mentions the output (RTSTRUCT objects) must be used with other software (like Treatment Planning Systems) for review and editing. |
| K231871 | Envisionit Deep AI Ltd | Radify Triage | The summary states the software "provides case-level output available in the PACS for worklist prioritization or triage" and displays the result "through the worklist interface of PACS", indicating it integrates with another system rather than having its own distinct user interface for result presentation. |
| K231928 | Ever Fortune.AI Co., Ltd. | EFAI RTSUITE CT HCAP-Segmentation System | The summary explicitly states in Section 4 (Device Description) that "The device does not offer a user interface..." and "...no user interaction is required, nor provided." The comparison table on page 8 also lists "No" under "User Interface" for the proposed device. |
| K231955 | Carlsmed, Inc. | aprevo® Digital Segmentation | The comparison table under "User Interaction" explicitly states the subject device "does not include any viewer" and that its outputs are reviewed "utilizing 3rd party software". |
| K232053 | Nanowear Inc. | SimpleSense-BP, SimpleSense-BP Software Application | The summary describes the "SimpleSense-BP Software Application" as an algorithm running on Nanowear servers that processes physiological data and returns blood pressure outputs to the "SimpleSense Mobile Application and/or SimpleSense webserver for display". The comparison table also explicitly states "No on-device display" and lists the software interface as "iOS or Android OS Mobile Application and web browser", indicating the core BP software itself does not have a direct GUI. |
| K232083 | Aidoc Medical, Ltd. | BriefCase-Quantification | The summary describes the software running on a server, processing images, and transferring/exporting the output (a summary report) to another image review software (PACS or desktop application) for presentation to the user. This indicates the core software itself does not have a direct user interface for the end-user. |
| K232096 | Screenpoint Medical B.V. | Transpara Density 1.0.0 | The summary states in the device description section that "To operate in a clinical environment the software must be embedded in a software application that generates output in standardized formats (e.g. DICOM) and handles communication with external devices (such as PACS systems)." Additionally, in the predicate device comparison table, under "Image Output", it explicitly states "None" for Transpara Density, contrasting with the predicate device which can output a density map for visualization. This indicates it relies on another application for interaction and output presentation, lacking its own direct user interface. |
| K232331 | InVision Medical Technology Corporation | InVision Precision LVEF (LVEF) | The comparison table on page 5 explicitly states under "User Interface" that the subject device (InVision Precision) "Uses the interface of approved PACS system", whereas the predicate device "Includes own user interface". This indicates the software does not have its own GUI. |
| K232363 | Viz.ai, Inc. | Viz HDS, Viz Volume Plus, Viz ICH+ | The summary describes the software running on a cloud server, processing scans automatically, and exporting the results as DICOM files to a separate PACS system for physician review, indicating the primary interaction with the output occurs outside the described software itself. |
| K232384 | VideaHealth, Inc. | Videa Dental Assist | The summary states, "The device itself is available as a service via an API (Application Programming Interface)... VDA is accessed by the dental practitioner through their dental image viewer." This indicates interaction happens programmatically via an API and through a separate viewing software, not a dedicated GUI for VDA itself. |
| K232410 | Milvue | SmartChest | The summary describes the software output as being sent to PACS or other DICOM storage platforms for worklist prioritization via DICOM tags and a secondary capture image, indicating interaction occurs within existing systems rather than a dedicated GUI for the software itself. |
| K232613 | Innolitics, LLC | CT Cardiomegaly | The summary repeatedly describes the software as a "command line software application" and states its output is a "summary report" (in PDF and JSON format), indicating it lacks a traditional graphical user interface. |
| K232699 | Anumana, Inc. | Low Ejection Fraction AI-ECG Algorithm | The summary explicitly states under "Technological Characteristics" on page 5: "The Low Ejection Fraction AI-ECG Algorithm does not provide a graphical user interface (GUI) of its own." |
| K232856 | Siemens Healthcare GmbH | Syngo Carbon Clinicals | The comparison table explicitly states "Not offered by Syngo Carbon Clinicals" under the "Graphical user interface" specification for the subject device. |
| K233030 | MRIguidance B.V | BoneMRI | The summary explicitly states in the comparison table (Table 1, page 6) under "User Interface" that there is "None – enhanced images are viewed on existing PACS workstations." It also describes the software as a "server application" (page 5) where "Reading of the resulting BoneMRI images is performed using regular DICOM compatible medical image viewing software." |
| K233108 | VinBigData Joint Stock Company | VinDr-Mammo | The summary describes the software running on a server, utilizing an "API Cognitive service" whose outputs are sent via API to clinical IT systems (PACS/Workstation) for viewing on a radiology worklist, indicating it operates without its own GUI for the end-user radiologist. |
| K233409 | Eko Health, Inc. | Eko Low Ejection Fraction Tool (ELEFT) | The substantial equivalence table explicitly states under "Software Display" for the ELEFT device: "Application Programming Interface (API) only, no user interface". |
| K233438 | Beacon Biosignals, Inc. | SleepStageML | The summary states that users provide input EDF files via a secure transfer system and receive back EDF+ files containing annotations, which are then reviewed "via the users' PSG viewing software", implying SleepStageML itself does not have a GUI for result review. |
| K233549 | Tempus AI, Inc. | Tempus ECG-AF | The summary explicitly states on page 6 (chunk {5}) under "Device Description": "Tempus ECG-AF does not have a dedicated user interface (UI)." It further describes that input and output are handled via "standard communication protocols (e.g. API, file exchange) with other medical systems". |
| K233755 | B-Secur Limited | HeartKey® Rhythm | The comparison table on page 9 explicitly states "No primary display or GUI" for the subject device (HeartKey® Rhythm). |
| K234042 | Ever Fortune.AI Co., Ltd. | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | The summary explicitly states in the "Substantial Equivalence" section (page 10) that "The proposed device does not consist of a typical user interface which allows users to interact with images using typical image navigation and manipulation tools". It also describes the output as a JSON message for integration with other systems (page 4) and lists "No" for features like "Image navigation and manipulation tools", "2D image review", and "Report creation" in the comparison table (page 5). |
| K240013 | Ultromics Limited | EchoGo Heart Failure (2.0) | The "Device Description" section explicitly states: "EchoGo Heart Failure 2.0 is fully automated and does not comprise a graphical user interface." |
| K240290 | Subtle Medical, Inc. | AiMIFY (1.x) | The summary explicitly states on page 5: "It is a post-processing software that does not directly interact with the MR scanner and does not have a graphical user interface." and "Because the software runs in the background, it has no user interface." The technological comparison table on page 6 also confirms "User Interface: None". |
| K240291 | Ever Fortune.AI, Co., Ltd. | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | The summary states the software "makes case-level output available to a PACS/workstation for worklist prioritization or triage" and provides a "passive notification through the PACS/workstation", indicating it integrates with other systems rather than having its own primary user interface. It also explicitly mentions it is "not intended to direct attention to specific portions or anomalies of an image". |
| K240369 | BunkerHill Health | CAC (gated) Algorithm | The summary states the output (quantification and segmentation) can be viewed in a patient report or a diagnostic image viewer, implying these are separate systems and the CAC (gated) software itself does not have its own interactive user interface for displaying results directly. |
| K240408 | Epitel, Inc | REMI-AI Rapid Detection Module (REMI-AI RDM) | The summary states that REMI-AI RDM produces notifications and annotations which are "provided to the REMI System (K230933) in an interoperable way" and that the "REMI System displays this information through the REMI Mobile medical application, and provides the RDM outputs as annotations in the EEG record." This indicates the REMI-AI RDM module itself does not have a direct user interface; its outputs are handled by the broader REMI System. |
| K240680 | Oxford Brain Diagnostics Ltd | CDM Insights | The comparison table on page 6 explicitly states "No User Interface (UI)" for the new device (CDM Insights) under both "User Interface Confirmation" and "User Interface Configuration". |
| K240712 | icometrix NV | icobrain aria | The summary explicitly states on page 9 that "the end user only interacts with the electronic output of the device (including annotated DICOM images)", indicating no direct GUI interaction with the processing software itself. |
| K240769 | DiA Imaging Analysis Ltd. | LVivo IQS | The summary describes the software as an "Algorithm with API" and a "software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device", indicating it lacks its own user interface and operates via an API within another system. |
| K240786 | HeartLung Corporation | AutoChamber | The summary explicitly states on page 5: "The AutoChamber Software is executed via a parent software which provides the necessary input and visualizes the output data. The software itself does not offer user controls or access." |
| K240845 | AZmed SAS | Rayvolve | The summary describes the software as interacting with DICOM Node servers (like PACS) and clinical-grade image viewers, processing DICOM files, and outputting predictions/processed images back to these systems for viewing (e.g., "Image viewing: PACS system"). This implies it operates in the background without its own direct user interface for image display or result interaction. |
| K240860 | Ultromics Limited | EchoGo Amyloidosis (1.0) | The summary explicitly states in Section 4 (Device Description): "EchoGo Amyloidosis 1.0 is fully automated without a graphical user interface." |
| K240953 | Exo Imaging | AI Platform 2.0 (AIP002) | The summary states, "In addition, the Al modules are provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which are modules, are medical device accessories." This indicates it's not a standalone application with its own GUI, but rather a backend component accessed via an API by other software. |
| K241098 | CorTechs Labs, Inc. | NeuroQuant | The summary explicitly states in Section 4 (Device Description): "The software is designed without the need for a user interface after installation." |
| K241108 | Remedy Logic Inc. | RemedyLogic AI MRI Lumbar Spine Reader | The summary states in section 4 (Device Description) that "The PACS serves as the RAI user interface" and describes the software as consisting of a cloud-based algorithm and "an API to integrate directly with the client's PACS system," implying interaction occurs through the PACS rather than a dedicated GUI for the RAI software itself. |
| K241112 | Aidoc Medical, Ltd. | BriefCase-Quantification | The summary states the software runs on a server, processes images, and then the output (analysis, preview image) is "transferred to an image review software (desktop application), and forwarded to user review in the PACS," indicating the core software itself does not have the primary user interface for review. |
| K241197 | Medicalgorithmics S.A. | DeepRhythmAI | The summary explicitly states on page 5, "DeepRhythmAl doesn't have User Interface therefore it should be integrated with the external visualization software..." and confirms this in the comparison table on page 6 under "Display or Graphical User Interface (GUI)" with "No primary display or GUI". |
| K241329 | Subtle Medical, Inc. | SubtleSYNTH (1.x) | The summary explicitly states in the "Device Description Summary" section: "Because the software runs in the background, it has no user interface." |
| K241490 | MVision AI Oy | Contour+ (MVision AI Segmentation) | The summary explicitly states that the produced segmentation templates "must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve", implying the software itself lacks the interface for these user interactions. |
| K241561 | Therapixel | MammoScreen BD | The summary states the software "takes as input a folder with images in DICOM formats and outputs a breast density assessment in a form of a JSON file" and that these "outputs can be integrated with compatible third-party software such as the MammoScreen Web-UI interface, PACS viewer... or within reporting software", indicating the core software processes data and outputs it for use/display in other systems rather than having its own integrated GUI. |
| K241593 | Gleamer SAS | BoneMetrics (US) | The summary describes the software as receiving images automatically from a DICOM source, processing them "without requiring any user inputs", generating result files (DICOM format with overlays), and sending these files to a DICOM destination (like PACS) where users can visualize them. This workflow implies the software operates in the background and its output is viewed in a separate system, indicating it lacks its own interactive GUI for the analysis and result viewing process. |
| K241620 | Gleamer SAS | ChestView US | The summary describes the software as receiving images automatically from a DICOM source (potentially via an API), processing them, and sending result files (annotated DICOM images) to a DICOM destination (like PACS) for visualization, implying it operates in the background without its own interactive GUI for the end-user. |
| K241727 | Aidoc Medical, Ltd. | BriefCase-Triage | The summary describes the software as an "algorithm analysis module" running on a server, whose output (notifications and preview images) is "transferred to an image review software (desktop application)" or integrated with an "image communication platform". This indicates the core software itself does not have a direct user interface for the end-user, relying on other software for display and interaction. |
| K241747 | DeepHealth, Inc | Saige-Dx | The summary states the software outputs results as DICOM Structured Report (SR) and Secondary Capture (SC) objects, which are then used by external systems ("viewing workstation", "PACS or other worklist software") for display, implying Saige-Dx itself does not have a direct user interface for visualization. |
| K241770 | Siemens Healthcare GmbH | Prostate MR AI (VA10A) | The comparison table on page 7 explicitly states under "Visualization Features" for the subject device: "Prostate MR AI does not include a standalone graphical user interface. Rather, it is a plug-in device that is intended to be used with a separate hosting application..." |
| K241831 | ScreenPoint Medical B.V. | Transpara (2.1.0) | The summary states: "Implementation of a user interface for end users in a medical workstation is to be provided by third parties." This indicates that Transpara itself does not have the end-user GUI; it processes data and sends the output (results) to other systems (like workstations) which are responsible for displaying it. |
| K241837 | Limbus AI Inc. | Limbus Contour | The summary explicitly states in the comparison table (Section VI, Result Visualization row) that "Limbus Contour has no data visualization. Data processing is automated and does not require user interaction. A control interface is provided for system administration and configuration only. Visualization software must be used to facilitate the review and edit of the generated contours." This confirms it lacks a primary GUI for its core function and relies on exporting data. |
| K241847 | Imbio, Inc | Imbio PHA (4.0.0) | The summary explicitly states, "The Imbio PHA is a single command-line executable program... and thus the user interface is minimal" and lists the "Interface" as "Command-line" in the device characteristics table. |
| K241891 | Imvaria, Inc | ScreenDx | The summary describes the software architecture as consisting of an Image Receiver API, an Analysis System, and an Output API, indicating interaction via programming interfaces rather than a direct user interface. It explicitly states, "No analyzed images or other visually assessed features are output by the device," and mentions the output is transmitted via the Output API for integration into other systems (e.g., EHR, messaging system, worklist software). |
| K241960 | Nox Medical ehf | DeepRESP | The summary explicitly states the software has "A web Application Programming Interface (API) intended to interface with a third-party client application" and that "The results of the analyzed data are then transferred to another software for manual scoring, display and reporting". It also describes it as "API-based software". |
| K242171 | Milvue | TechCare Trauma | The summary describes the software receiving images automatically, processing them without manual intervention, and sending results (images/reports) to DICOM destinations for viewing on other compatible viewers, indicating it operates without its own GUI. |
| K242203 | Aidoc Medical, Ltd. | BriefCase-Quantification | The summary states the software runs on a server, processes images, and the output is "transferred to an image review software (desktop application), and forwarded to user review in the PACS" or "exported in DICOM format, and are sent to a PACS destination for review". This indicates the core software itself does not have a direct user interface for viewing results, relying instead on other systems. |
| K242334 | Ezra AI, Inc. | Ezra Flash | The summary explicitly states in the Device Description section "the device has no interface" and repeats in the comparison table under "User Interface" that it has "None - enhanced images are viewed on existing PACS workstations". |
| K242342 | BrightHeart | Fetal EchoScan | The device description states the output consists of a "record summary table" and an "exam summary table", and compares it to a predicate device that "generates a report", without mentioning any interactive GUI. |
| K242359 | Exo Inc | Strain AI (SAI001) | The summary states on page 5: "The software does not have a built-in viewer; instead, it integrates into a third-party ultrasound imaging device." |
| K242683 | Quibim S.L. | QP-Prostate® CAD | The summary repeatedly states that the software's results (DICOM outputs, overlays) are displayed on *third-party* DICOM workstations and PACS, implying the software itself does not have its own user interface for displaying results. |
| K242821 | Ever Fortune.AI, Co., Ltd. | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | The summary explicitly states on page 9 that the proposed device "provides notification as a text based JSON file" to a PACS/workstation, contrasting it with the predicate device which provided preview images. This description indicates the software's output is data intended for another system rather than having its own graphical user interface. |
| K242837 | Aidoc Medical, Ltd. | BriefCase-Triage | The summary describes the software running on a server, processing images, and transferring its output (notifications and preview images) to a separate "image review software (desktop application)" where the user receives the notification and views the preview. This indicates the core BriefCase-Triage software itself does not have a direct user interface for the end-user radiologist, functioning more like a backend or headless component integrated with another system. |
| K242919 | V5med Inc. | V5med Lung AI | The summary indicates the output is "DICOM GSPS (Grayscale Softcopy Presentation State)" and explicitly contrasts it with a predicate device (AVIEW) by stating V5med Lung AI lacks "specific viewer capabilities of AVIEW", implying it outputs results for display in other software rather than having its own integrated GUI/viewer. The mention of testing "API endpoints" also supports a headless/backend architecture. |
| K243158 | TeraRecon, Inc. | TeraRecon Aorta.CT (1.1.0) | The summary states the software is a "containerized application" and its "outputs are DICOM result files which may be viewed utilizing DICOM-compliant systems" or "external viewer devices", implying it does not have its own user interface for viewing results. |
| K243229 | BunkerHill Health | Bunkerhill AVC | The summary states the output (quantification and region of interest) can be viewed in a patient report or a diagnostic image viewer (like PACS) as part of the standard workflow, implying the software itself doesn't have its own interactive GUI for viewing results. |
| K243250 | Subtle Medical, Inc. | SubtleHD (1.x) | The summary explicitly states in the Device Description section "...the device has no user interface" and confirms this in the comparison table under the "User Interface" row, listing it as "None". |
| K243331 | DiA Imaging Analysis Ltd. | LVivo Seamless | The summary describes the software as a "standalone application that... runs offline on a server", accepts data automatically, performs processing, and "results are sent to the PACS and are evaluated by a healthcare professional", strongly indicating a server-based, automated process without its own interactive GUI for result viewing. |
| K243548 | Aidoc Medical, Ltd. | BriefCase-Triage | The summary states the software runs on a "linuxbased server" and its output is "transferred to an image review software (desktop application)" where the user receives notifications and preview images, implying the core server software itself does not have a direct user interface. |
| K243688 | DeepHealth, Inc. | Saige-Dx (3.1.0) | The summary states that Saige-Dx outputs results as DICOM Structured Report (SR) and Secondary Capture (SC) objects, which are then used by a separate "viewing workstation" or "PACS or other worklist software" to display markings or a summary report, implying Saige-Dx itself does not have the primary user interface for result visualization. |
| K243705 | DeepHealth, Inc | Saige-Density (2.5.0) | The device description states that the software outputs DICOM files (a structured report and a secondary capture report) which "may be viewed on a mammography viewing workstation", implying Saige-Density itself does not provide the primary viewing interface for its results. |
| K243808 | AZmed | Rayvolve PTX-PE | The summary describes the software as providing "study-level output available in DICOM node servers for worklist prioritization or triage", displaying results "through the worklist interface of PACS/workstation", having "No markup on the original image", and using "Passive notification" by flagging images within existing systems. This indicates it operates in the background and integrates with other systems rather than having its own interactive GUI. |
| K243831 | AZmed | Rayvolve LN | The summary describes the software interacting with DICOM Node servers and clinical-grade image viewers, processing images, and outputting a marked image viewed within those external systems, implying it operates as a backend process without its own dedicated GUI for the end-user. |
| K250035 | MIM Software Inc. | Contour ProtégéAI+ | The summary repeatedly states that "Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI", indicating the core software lacks its own interface for these user interactions. |
