--- author: - Yujan Shrestha date: '2026-01-13' description: Comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights. related: [] title: '2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances' topics: - AI/ML --- ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e9bd5b7a75480e7af59cefee1636648.png) ### Executive Summary - **92** AI/ML-related FDA clearances in 2025, with image-processing and workflow software product codes dominating. - **Coronary CT** was a major category: **9 plaque-related** tools, **7 CAC-related** tools, and **3 FFR/FFRct/QFR-related** tools were cleared. - Hospital outpatient payment for CCTA increased in 2025 (per ACC reporting). New 2026 CPT updates include Category I codes tied to CT-derived FFR and CT perfusion. - **8 of 92** 2025 clearances were PCCP-authorized, spanning imaging software, cardiology analytics, and consumer device features. - Multiple companies announced financing rounds or IPO filings around the time of their 510(k) clearances (see case studies below). 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 ### 2025 Cardiology AI/ML Clearances at a Glance | Metric | Value | |------------------------------------------|-------| | Total 2025 AI/ML cardiology clearances | 92 | | Unique applicants | 69 | | Unique manufacturers deduplicated | 63 | | SaMD | 59 | | Non-SaMD | 33 | | Panel: Radiology | 69 | | Panel: Cardiovascular | 19 | | Panel: Other | 4 | | 510(k) type: Traditional | 80 | | 510(k) type: Special | 11 | | 510(k) type: Abbreviated | 1 | | Median FDA review time days to clearance | 149 | | Mean FDA review time days to clearance | 155.2 | | PCCP-authorized | 8 | 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 ### How fast were these cleared? ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e7bd5b7a7548011942ef366ac365e74.png) Review time statistics are shown below. | 510(k) type | N | Median days | Mean days | |-------------|-----|-------------|-----------| | Abbreviated | 1 | 117 | 117 | | Special | 11 | 28 | 68.2 | | Traditional | 80 | 153.5 | 167.6 | Special 510(k) accounted for 11 of 92 clearances. Traditional 510(k) accounted for 80 of 92 clearances. 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 ### Manufacturer landscape with deduplication If you look at applicant names, you'll see 69 unique applicants. If you "deduplicate" obvious corporate families (for example: GE's multiple legal entities, Philips' sub-entities), the list becomes **63 manufacturer groups**. #### Top manufacturer groups by 2025 clearance count ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e7bd5b7a75480b48f36edf0282ab591.png) | Manufacturer | 2025 Clearances | First AI/ML Clearance | First Year? | |----------------------------------------------|-----------------|-----------------------|-------------| | Philips | 7 | 2013 | No | | Siemens Healthineers | 6 | 2014 | No | | Shanghai United Imaging Healthcare Co., Ltd. | 6 | 2020 | No | | GE HealthCare | 5 | 2018 | No | | BrightHeart | 3 | 2024 | No | | BunkerHill Health | 3 | 2024 | No | | Canon | 3 | 2019 | No | | Artrya Limited | 2 | 2025 | Yes | | DiA Imaging Analysis Ltd. | 2 | 2024 | No | | TeraRecon, Inc. | 2 | 2020 | No | Incumbent imaging OEMs (Siemens, Philips, GE, Canon, Fujifilm) appear repeatedly. A large share of the long tail consists of single-clearance companies. #### New entrants signal **27 of the 63 manufacturer groups appear for the first time (as a group heuristic) in 2025**, contributing **28 of the 92** clearances (about 30%). Treat that as a directional signal, not a legal fact, because naming conventions and subsidiaries can hide earlier activity. 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 ### Product codes: what the volume is really about ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e8bd5b7a75480549bf9ec5a29646278.png) | Product code | Count (2025) | |--------------|--------------| | QIH | 28 | | IYN | 7 | | JAK | 6 | | LNH | 6 | | QAS | 5 | | DQK | 4 | | QKB | 4 | | QYE | 3 | | SDJ | 2 | | QJU | 2 | | QHA | 2 | | OWB | 2 | #### What the top codes mean in plain English These definitions come from FDA product classification sources. - **QIH** is Automated Radiological Image Processing Software---a broad category covering AI/ML tools that process medical images. - **IYN** is Ultrasonic Pulsed Doppler Imaging System---ultrasound hardware that may include AI features. - **JAK** is Computed Tomography X-Ray System---CT scanner hardware, often with integrated AI capabilities. - **LNH** is Nuclear Magnetic Resonance Imaging System---MRI hardware that may bundle AI functionality. - **QAS** is Radiological Computer-Assisted Triage and Notification Software---AI that flags urgent findings and prioritizes worklists. - **DQK** is Computer, Diagnostic, Programmable---a cardiovascular diagnostic computer category. - **QKB** is Radiological Image Processing Software for Radiation Therapy---software for treatment planning, not detection/diagnosis. - **QYE** is Reduced Ejection Fraction Machine Learning-Based Notification Software---a cardiovascular code (not radiological) for ECG-based heart failure screening. This mix of hardware and software codes helps explain why a \"cardiology\" themed list contains so much radiology-adjacent content. In practice, many cardiac AI/ML products live operationally inside radiology infrastructure (CT, MRI, ultrasound), while others like QYE represent pure cardiovascular software that analyzes ECG signals rather than images. 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 ### PCCPs in 2025: the update cadence story is real ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e7bd5b7a754803eacd2e3645e0ef1e1.png) **8 clearances** in 2025 were PCCP-authorized. | decisiondate | knumber | applicant | devicename | productcode | type | |--------------|---------|-------------------------|-------------------------------------------------------------|-------------|-------------| | 2025-09-11 | K250507 | Apple Inc. | Hypertension Notification Feature (HTNF) | QXO | Traditional | | 2025-04-04 | K242807 | Deski | HeartFocus (V.1.1.1) | QJU | Traditional | | 2025-07-28 | K250652 | Anumana, Inc. | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | QYE | Traditional | | 2025-01-15 | K243065 | Caption Health, Inc. | Cardiac Guidance | QJU | Traditional | | 2025-05-07 | K243684 | BrightHeart | BrightHeart View Classifier | QIH | Traditional | | 2025-06-05 | K251456 | BrightHeart | BrightHeart View Classifier | QIH | Special | | 2025-07-18 | K250902 | HeartFlow, Inc. | HeartFlow Analysis | PJA | Traditional | | 2025-04-03 | K242551 | Siemens Healthcare GmbH | syngo Dynamics (Version VA41D) | QIH | Traditional | PCCP allows manufacturers to make certain pre-specified changes to their device without submitting a new 510(k). It requires a quality system capable of monitoring and change management. 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 ### Coronary CT: CAC, Plaque, and CT-FFR Clearances ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e7bd5b7a754802d9ae0efb06495d286.png) #### 2025 clearance count for three coronary CT sub-areas - **Plaque quantification / plaque characterization:** 9 cleared devices - **CAC / coronary calcium scoring:** 7 cleared devices - **FFR / FFRct / QFR:** 3 cleared devices These counts are directional estimates based on device names and intended use descriptions. #### Plaque-related devices (2025) | decisiondate | knumber | applicant | devicename | productcode | type | |--------------|---------|----------------------------------------------|--------------------------------------------------------|-------------|-------------| | 2025-03-07 | K242338 | Cleerly, Inc. | Cleerly LABS (v2.0) | QIH | Special | | 2025-03-27 | K243038 | Artrya Limited | Salix Central | QIH | Traditional | | 2025-05-14 | K242624 | Shanghai United Imaging Healthcare Co., Ltd. | Medical Image Post-processing Software (uOmnispace.CT) | QIH | Traditional | | 2025-06-18 | K243672 | GE Medical Systems SCS | CardIQ Suite | JAK | Traditional | | 2025-07-18 | K250902 | HeartFlow, Inc. | HeartFlow Analysis | PJA | Traditional | | 2025-08-20 | K251837 | Artrya Limited | Salix Coronary Plaque (V1.0.0) | QIH | Traditional | | 2025-09-04 | K251656 | Careverse Technology Pte. Ltd. | Careverse CoronaryDoc (Careverse CoronaryDoc) | QIH | Traditional | | 2025-10-27 | K251027 | Circle Cardiovascular Imaging Inc. | cvi42 Coronary Plaque Software Application | QIH | Traditional | | 2025-11-28 | K252217 | Canon Medical Informatics, Inc. | CT VScore+ | JAK | Traditional | #### CAC-related devices (2025) | decisiondate | knumber | applicant | devicename | productcode | type | |--------------|---------|----------------------------------------------|--------------------------------------------------------|-------------|-------------| | 2025-01-27 | K243229 | BunkerHill Health | Bunkerhill AVC | JAK | Traditional | | 2025-03-27 | K243038 | Artrya Limited | Salix Central | QIH | Traditional | | 2025-05-14 | K242624 | Shanghai United Imaging Healthcare Co., Ltd. | Medical Image Post-processing Software (uOmnispace.CT) | QIH | Traditional | | 2025-06-18 | K243672 | GE Medical Systems SCS | CardIQ Suite | JAK | Traditional | | 2025-08-20 | K251837 | Artrya Limited | Salix Coronary Plaque (V1.0.0) | QIH | Traditional | | 2025-10-23 | K250288 | TeraRecon, Inc. | TeraRecon Cardiovascular.Calcification.CT | QIH | Traditional | | 2025-11-28 | K252217 | Canon Medical Informatics, Inc. | CT VScore+ | JAK | Traditional | #### FFR-related devices (2025) | decisiondate | knumber | applicant | devicename | productcode | type | |--------------|---------|-------------------|--------------------|-------------|-------------| | 2025-04-04 | K243769 | QFR Solutions bv | QFR (3.0) | QHA | Traditional | | 2025-07-18 | K250902 | HeartFlow, Inc. | HeartFlow Analysis | PJA | Traditional | | 2025-10-17 | K251355 | SpectraWAVE, Inc. | X1-FFR | QHA | Traditional | 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 ### Beyond Coronary CT: Other Notable 2025 Trends #### 1) Heart failure and low ejection fraction screening Multiple 2025 clearances involve EF estimation or low EF screening. Representative example: - **Tempus ECG-Low EF** (Tempus AI) cleared in 2025. Eko Health raised a growth round in 2025 (reported publicly). #### 2) Valvular disease Valvular analysis shows up repeatedly. Echo remains a common modality for structural heart imaging. AI features often focus on chamber quantification, measurement automation, and quality support. #### 3) ECG AI and consumer-grade screening Apple\'s hypertension notification feature (K250507) was cleared in 2025 and is PCCP-authorized. #### 4) Workflow and triage tools Product code QAS (triage/notification) appeared in 5 clearances in 2025. 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 ### Financing Events Near 2025 Clearances ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e8bd5b7a7548055b284e7d3b2e6b0aa.png) Below are case studies showing FDA clearances alongside publicly reported financing and corporate events. 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 ### Case study: HeartFlow #### Timeline (public sources) - **March 26, 2025:** HeartFlow reported raising **\$98 million** via a convertible note financing (Reuters coverage). - **July 17, 2025:** HeartFlow filed for a U.S. IPO (Reuters). - **July 18, 2025:** HeartFlow Analysis received FDA clearance (K250902). - **August 2025:** HeartFlow\'s IPO pricing and debut were covered by Reuters, including a reported valuation and proceeds. 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 ### Case study: Cleerly #### Timeline (public sources) - **December 2024:** Cleerly announced **\$106 million** in growth financing (public reporting). - **December 2024:** Cleerly announced the AMA CPT Editorial Panel approved a **Category I CPT code 75577** for plaque analysis from CCTA, effective January 1, 2026 (company announcement). - **March 7, 2025:** Cleerly LABS v2.0 received FDA clearance (K242338). 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 ### Case study: Anumana #### Timeline (public sources) - Anumana has received multiple Breakthrough Device Designations for ECG-AI use cases (publicly discussed). - Anumana announced a Series C financing and strategic collaborations, including Boston Scientific participation and Mayo Clinic Platform collaboration (Business Wire reporting). - **July 28, 2025**: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm received FDA clearance (K250652). 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 ### Case study: Eko Health - **June 5, 2024: \$41 million in Series D financing** - **August 12, 2025:** Eko Duo ECG System received FDA clearance (K251494). 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 ### Case Study: Artrya
For pre-revenue, first time FDA clearance medical device companies, FDA rejections can result in significant stock price and market cap movements. On the flipside, FDA clearances can send the stock price skyrocketing.
- **Nov 26, 2021:** Artrya began trading on the ASX. BioWorld reported the IPO offer price was **A\$1.35** and the stock **closed its first trading day at A\$1.52** (public reporting). - **Jun 24, 2022:** The FDA **rejected Artrya's 510(k)** for Salix Coronary Anatomy, citing **not substantially equivalent** to the chosen predicate (public reporting). - **Jul 26, 2022:** In an ASX quarterly update, Artrya stated the FDA advised in **June 2022** that the company's 510(k) application **was not approved** because the device was **not substantially equivalent**, and that the FDA **invited resubmission** (company announcement). - **Mar 27, 2025:** Artrya reported that the FDA **cleared Salix Coronary Anatomy** for commercial sale in the U.S. (company announcement). The FDA 510(k) documentation for **K243038** supports this clearance context (FDA documentation). - **Aug 20, 2025:** FDA 510(k) **K251837** for **Salix Coronary Plaque (V1.0.0)** lists Artrya as the applicant (FDA database). - **Aug 21, 2025:** Artrya announced it received FDA 510(k) clearance for the **Salix Coronary Plaque** module (company announcement). The FDA 510(k) summary document for **K251837** provides the supporting clearance documentation (FDA documentation). ### Predicate network analysis: which devices are the "hubs"? ![](/img/articles/2025_Year_in_Review_Cardiology_AIML_SaMD_510k_Clearances-2e8bd5b7a754806dacefe8a7a57de527.png) #### Top "predicated by" devices (direct) | knumber | year | applicant | devicename | productcode | direct_cited_by | indirect_cited_by | |-----------|------|-------------------------------------------------------------------|---------------------------------------------|-------------|-----------------|-------------------| | K213998 | 2022 | Circle Cardiovascular Imaging Inc | cvi42 Auto Imaging Software Application | QIH | 6 | 7 | | K203256 | 2021 | Imbio, LLC | Imbio RV/LV Software | QIH | 6 | 9 | | DEN190040 | 2020 | Bay Labs, Inc. | Caption Guidance | QJU | 4 | 5 | | K232699 | 2023 | Anumana, Inc. | Low Ejection Fraction AI-ECG Algorithm | QYE | 4 | 4 | | K222463 | 2022 | Ultromics Limited | EchoGo Heart Failure | QUO | 4 | 6 | | K210085 | 2021 | Zebra Medical Vision Ltd. | HealthCCSng | JAK | 4 | 7 | | K230223 | 2023 | Bunkerhill, Inc | iCAC Device | JAK | 3 | 3 | | K173780 | 2018 | Bay Labs, Inc. | EchoMD Automated Ejection Fraction Software | LLZ | 3 | 10 | | K201555 | 2020 | Ultromics Ltd | EchoGo Pro | POK | 3 | 4 | | K210791 | 2021 | [eko.ai](http://eko.ai/) Pte. Ltd. d/b/a [Us2.ai](http://us2.ai/) | Us2.v1 | QIH | 3 | 3 | ### Prediction
Cardiology AI/ML clearance volume increased from 62 (2024) to 92 (2025).
Cardiology AI/ML clearance volume increased from 62 (2024) to 92 (2025). A simple growth extrapolation suggests 2026 could land around **95 to 125** decisions in cardiology AI/ML.

Appendix: Raw Data

knumber type panel applicant devicename productcode subsequent_product_codes decision datereceived decisiondate
K252217 Traditional Radiology Canon Medical Informatics, Inc. CT VScore+ JAK SESE 2025-07-15 2025-11-28
K252000 Traditional Radiology Shanghai United Imaging Healthcare Co., Ltd. uDR Arria & uDR Aris KPR SESE 2025-06-27 2025-11-26
K251293 Traditional Cardiovascular Icardio.Ai CardioVision QUO SESE 2025-04-25 2025-11-21
K250330 Traditional Radiology Pie Medical Imaging B.V. 3mensio Workstation QIH SESE 2025-02-05 2025-11-03
K250337 Traditional Radiology ViTAA Medical Solutions Inc. AiORTA - Plan QIH SESE 2025-02-06 2025-10-30
K250882 Traditional Cardiovascular Huxley Medical SANSA HSAT MNR BZQ, MWJ SESE 2025-03-24 2025-10-29
K251027 Traditional Radiology Circle Cardiovascular Imaging Inc. cvi42 Coronary Plaque Software Application QIH SESE 2025-04-02 2025-10-27
K250288 Traditional Radiology TeraRecon, Inc. TeraRecon Cardiovascular.Calcification.CT QIH SESE 2025-01-31 2025-10-23
K252665 Traditional Radiology Avatar Medical brAIn Shoulder Positioning QIH SESE 2025-08-25 2025-10-20
K251355 Traditional Radiology SpectraWAVE, Inc. X1-FFR QHA SESE 2025-04-30 2025-10-17
K251602 Traditional Radiology Canon Medical Systems Corporation Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging OWB SESE 2025-05-27 2025-10-10
K251082 Traditional Gastroenterology/Urology Procept BioRobotics HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) PZP SESE 2025-04-09 2025-10-10
K252105 Traditional Radiology Ligence, UAB Ligence Heart QIH SESE 2025-07-03 2025-09-26
K250649 Traditional Cardiovascular BunkerHill Health Bunkerhill ECG-EF QYE SESE 2025-03-04 2025-09-19
K251221 Traditional Cardiovascular Abbott Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) MXD SESE 2025-04-21 2025-09-17
K251386 Traditional Radiology Fujifilm Corporation ECHELON Synergy LNH SESE 2025-05-05 2025-09-17
K252595 Special Cardiovascular Sparrow Acoustics Inc. Stethophone Pro DQD SESE 2025-08-15 2025-09-12
K250507 Traditional Cardiovascular Apple Inc. Hypertension Notification Feature (HTNF) QXO SESE 2025-02-21 2025-09-11
K251316 Traditional Orthopedic Mazor Robotics Ltd. Mazor X System / Mazor X Stealth Edition OLO SESE 2025-04-29 2025-09-11
K244002 Traditional Radiology Angiowave Imaging, Inc. AngioWaveNet QIH SESE 2024-12-26 2025-09-10
K251656 Traditional Radiology Careverse Technology Pte. Ltd. Careverse CoronaryDoc (Careverse CoronaryDoc) QIH SESE 2025-05-30 2025-09-04
K251029 Traditional Radiology Vista AI, Inc. Vista OS, Vista AI Scan, RTHawk LNH SESE 2025-04-02 2025-08-21
K251837 Traditional Radiology Artrya Limited Salix Coronary Plaque (V1.0.0) QIH SESE 2025-06-16 2025-08-20
K251494 Traditional Cardiovascular Eko Health, Inc. Eko Foundation Analysis Software with Transformers (EFAST) DQD DPS, DQC SESE 2025-05-15 2025-08-12
K250569 Traditional Cardiovascular Philips France Commercial Cardiologs Holter Platform DPS SESE 2025-02-26 2025-08-06
K250941 Traditional Radiology GE Medical Systems, LLC Revolution Vibe JAK SESE 2025-03-28 2025-08-01
K250652 Traditional Cardiovascular Anumana, Inc. ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) QYE SESE 2025-03-04 2025-07-28
K251455 Special Radiology Philips Ultrasound LLC EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN ITX, IYO, OBJ, QIH SESE 2025-05-12 2025-07-24
K243781 Traditional Cardiovascular Edwards Lifesciences HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) DQK SESE 2024-12-09 2025-07-23
K250902 Traditional Radiology HeartFlow, Inc. HeartFlow Analysis PJA LLZ, QIH SESE 2025-03-26 2025-07-18
K250999 Traditional Radiology Samsung Medison Co., Ltd. V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System IYN ITX, IYO, LLZ, QIH SESE 2025-04-01 2025-07-18
K243547 Traditional Radiology Shanghai United Imaging Healthcare Co., Ltd. uMR Ultra LNH SESE 2024-11-15 2025-07-17
K251839 Traditional Radiology Shanghai United Imaging Healthcare Co., Ltd. uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) KPS SESE 2025-06-16 2025-07-17
K243397 Traditional Radiology Shanghai United Imaging Healthcare Co., Ltd. uMR 680 LNH MOS, QIH SESE 2024-10-31 2025-07-16
K251151 Traditional Radiology iSchemaView Rapid CTA 360 QAS SESE 2025-04-14 2025-07-16
K251342 Traditional Radiology GE Medical Systems Ultrasound and Primary Care Diagnostics EchoPAC Software Only / EchoPAC Plug-in QIH SESE 2025-04-30 2025-07-16
K250119 Traditional Cardiovascular Tempus AI, Inc. Tempus ECG-Low EF QYE SESE 2025-01-16 2025-07-15
K251169 Traditional Radiology GE Medical Systems Ultrasound and Primary Care Diagnostics Vivid Pioneer IYN ITX, IYO SESE 2025-04-15 2025-07-10
K243884 Traditional Radiology Caranx Medical TAVIPILOT OWB SESE 2024-12-18 2025-07-07
K251528 Traditional Radiology Siemens Medical Solutions USA, Inc. syngo.via MI Workflows; Scenium; syngo MBF QIH SESE 2025-05-19 2025-07-03
K243779 Traditional Radiology BunkerHill Health Bunkerhill Abdominal Aortic Quantification (AAQ) QIH SESE 2024-12-09 2025-07-01
K250484 Traditional Radiology PIUR Imaging GmbH PIUR tUS inside QIH SESE 2025-02-19 2025-06-30
K250670 Abbreviated Radiology Mycardium AI Limited EchoConfidence (USA) QIH SESE 2025-03-05 2025-06-30
K250151 Traditional Cardiovascular Eko.ai Pte. Ltd. d/b/a Us2.ai Us2.ca SDJ SESE 2025-01-21 2025-06-20
K243253 Traditional Radiology Esaote S.p.A. 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) IYN ITX, IYO, QIH SESE 2024-10-15 2025-06-18
K243672 Traditional Radiology GE Medical Systems SCS CardIQ Suite JAK SESE 2024-11-27 2025-06-18
K250886 Special Radiology Philips Ultrasound LLC EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems IYN ITX, IYO, OBJ, QIH SESE 2025-03-25 2025-06-18
K250685 Traditional Radiology Methinks Software S.L. Methinks NCCT Stroke QAS SESE 2025-03-06 2025-06-16
K250436 Traditional Radiology Siemens Shenzhen Magnetic Resonance Ltd. MAGNETOM Flow.Ace; MAGNETOM Flow.Plus LNH LNI, MOS SESE 2025-02-14 2025-06-16
K250443 Traditional Radiology Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile LNH LNI, MOS SESE 2025-02-14 2025-06-16
K240795 Traditional Cardiovascular Withings Withings ECG App QDA SESE 2024-03-22 2025-06-15
K251456 Special Radiology BrightHeart BrightHeart View Classifier QIH SESE 2025-05-12 2025-06-05
K250749 Traditional Cardiovascular PhysCade, Inc. PhysCade System DQK SESE 2025-03-12 2025-06-04
K251406 Special Radiology Aidoc Medical, Ltd. BriefCase-Triage QAS SESE 2025-05-06 2025-05-30
K250427 Traditional Radiology Taiwan Medical Imaging Co., Ltd. TAIMedImg DeepMets QKB QIH SESE 2025-02-14 2025-05-28
K243866 Traditional Cardiovascular InVision Medical Technology Corporation InVision Precision Cardiac Amyloid SDJ SESE 2024-12-17 2025-05-21
K243793 Traditional Radiology Philips Ultrasound LLC EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN ITX, IYO, OBJ, QIH SESE 2024-12-10 2025-05-21
K243617 Traditional Radiology Shanghai United Imaging Healthcare Co.,Ltd. uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis JAK SESE 2024-11-22 2025-05-16
K242624 Traditional Radiology Shanghai United Imaging Healthcare Co., Ltd. Medical Image Post-processing Software (uOmnispace.CT) QIH SESE 2024-09-03 2025-05-14
K251110 Special Radiology Philips Ultrasound LLC EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems SESE 2025-04-11 2025-05-09
K243812 Traditional Cardiovascular Volta Medical Volta AF-Xplorer DQK SESE 2024-12-11 2025-05-09
K243684 Traditional Radiology BrightHeart BrightHeart View Classifier QIH SESE 2024-11-29 2025-05-07
K242583 Traditional Cardiovascular ATsens Co.,Ltd. AT-Patch (ATP-C130/ATP-C70) DSH DQK, MLO SESE 2024-08-30 2025-05-02
K251071 Special Radiology BrightHeart Fetal EchoScan (v1.1) POK SESE 2025-04-07 2025-05-02
K250328 Traditional Radiology Canon Medical Systems Corporation UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program IYN, IYO SESE 2025-02-05 2025-04-30
K243651 Traditional Radiology GE Medical Systems SCS VersaViewer LLZ QIH SESE 2024-11-26 2025-04-21
K242129 Traditional Cardiovascular VitalConnect, Inc. VitalRhythm DQK DPS, QYX SESE 2024-07-22 2025-04-17
K242500 Traditional Radiology LARALAB GmbH LARALAB QIH SESE 2024-08-22 2025-04-16
K243145 Traditional Radiology Siemens Medical Solutions USA, Inc. syngo.CT LVO Detection QAS SESE 2024-09-30 2025-04-10
K243743 Traditional Neurology Holberg EEG AS autoSCORE (V 2.0.0) OMB SESE 2024-12-04 2025-04-09
K242807 Traditional Radiology Deski HeartFocus (V.1.1.1) QJU SESE 2024-09-17 2025-04-04
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