--- ai_summary: "- Set the regulatory strategy on a matched QIH predicate, skipping the\ \ Pre-Sub. \n- Designed the performance studies and statistical analysis plan,\ \ with acceptance criteria set before data collection. \n- Authored the full 510(k)\ \ in Medtech OS, including a 524B cybersecurity file. \n- Submitted 20 weeks after\ \ kickoff; FDA cleared NeuroDR 105 days after submission." fda_clearances: - k_number: K262134 device_name: NeuroDR clearance_date: '2026-10-07' product_codes: - QIH client_name: Deep Reasoning AI Inc. date: '2026-10-26' featured: true medical_panel: Neurology name: We Got an Automated Neurovascular CTA AI SaMD Cleared 105 Days After Submission services: - Medtech OS summary: Automated neurovascular CTA AI cleared 105 days after submission, with no Pre-Sub needed. tags: - AI/ML - 510k - Cybersecurity - DICOM - Image Processing testimonials: - person_name: Jeanne Usonis person_title: CFO, Deep Reasoning AI quote: We had started down the FDA path before and knew how much it would ask of a small team, so we spent time finding the right group to assist us. We could not have picked a better team to work with than Innolitics. They set a strategy that let us skip the Pre-Sub and go straight to the 510(k), and kept the schedule moving from the first strategy session to the clearance letter. When FDA came back with questions, they had a plan to us within days, and NeuroDR was cleared 105 days after we submitted. We look forward to continuing our work with Innolitics. - person_name: Di Chen, PhD person_title: Director of Research and Engineering, Deep Reasoning AI quote: Innolitics is the most technically capable regulatory team we know of. They understood our pipeline, from the AI model to centerline extraction, and they wrote all of the documentation for us. From our side it never felt like a separate regulatory project. It looked like the good engineering practice we were planning to follow. - person_name: Christy Mutchler, RT(R)(CT) person_title: VP, Solutions Management, 3DR Labs quote: The Innolitics team brought deep regulatory insight to ask challenging questions a clinical reviewer would ask that was both clinically meaningful and related to real-world interpretation in practice. --- ### Summary [Deep Reasoning AI](https://deepreasoningai.com/) Inc., a company founded by Cornell University AI professors, built NeuroDR: software that takes a head and neck CT angiography (CTA) scan and, with no manual steps, returns 3D and 2D views of the arteries that supply the brain. After a regulatory strategy phase that began in November 2025, we skipped the FDA Pre-Submission meeting because we already knew FDA\'s answers. The 510(k) build kicked off on February 2, 2026, and Innolitics submitted the eSTAR **20 weeks later**, on June 24. FDA cleared NeuroDR on October 7, 2026 ([K262134](https://fda.innolitics.com/search/K262134)), **105 days after submission**, after one round of FDA questions. ### The Problem CTA of the Circle of Willis (COW) and Carotid is a core exam for evaluating the carotid and vertebral arteries and the vessels of the brain. Before a physician can read those arteries well, someone has to strip away bone, soft tissue and veins, render the arterial tree in 3D, determine the centerline of the arteries, and trace each major artery along its length into a curved planar reformat. That post-processing takes skill and time, and it has to happen on every exam. Rapid stroke diagnosis is critical to identifying the appropriate intervention, as delays in treatment can lead to irreversible brain injury. Deep Reasoning AI\'s technology, which combines AI reasoning with deep learning, was already producing accurate anatomical models in minutes. The models worked. The path to the U.S. market still had to be built. ### The Challenge - **A fully automated, \"headless\" device in minutes.** NeuroDR runs in the background and sends its images straight to a DICOM node. No manual input is needed and results are generated in under 5 minutes. - **Ground truth for small vessels.** Expert annotation of the thin arteries inside the brain is hard to get right, and the performance results depended on it. - **Two partner companies, one submission.** Deep Reasoning AI built the advanced software. Its collaborator 3DR Labs conducted the performance studies and provided clinical expertise. FDA needed one consistent account of both. - **A cyber device.** A networked DICOM product reviewed under FDA\'s section 524B cybersecurity requirements. - **Startup constraints.** A small but capable engineering team, with every month of delay pushing back revenue. ### The Result - **20 weeks** from 510(k) kickoff to FDA submission - **105 days** from FDA submission to clearance - **24 meetings** with Innolitics, kickoff to submission - **About 1 hour a week** of the client team\'s time in meetings Innolitics wrote the submission. Deep Reasoning AI\'s engineers joined one hour-long sync a week, answered questions between meetings and reviewed drafts, while they kept building the product. **We skipped the Pre-Sub.** Most first-time AI device companies ask FDA their questions in a Pre-Submission meeting, which typically adds about three months before the 510(k) is filed. We had already answered the same questions on similar cleared AI imaging devices: the predicate, the study design, the acceptance criteria. Deep Reasoning AI went straight to building the 510(k), and FDA\'s review confirmed those answers. ### What We Did - **Skipped the Pre-Sub because we already knew the answers.** Our experience with comparable cleared devices told us what FDA would expect, so the months a Pre-Sub would have taken went into building the submission. - **Picked the predicate and wrote the claims to match it.** We built the strategy on Rapid Neuro3D ([K243350](https://fda.innolitics.com/search/K243350)), a cleared QIH device with the same intended use. NeuroDR\'s one new feature, separate views of the anterior and posterior circulation, went in as a visualization difference that raised no new questions of safety or effectiveness. - **Set acceptance criteria before the studies ran.** We set pass/fail thresholds from the predicate\'s published performance, so Deep Reasoning AI knew where it stood before collecting any data. - **Designed the performance studies and the statistical analysis plan.** We designed the studies and wrote the statistical analysis plan. Deep Reasoning AI and 3DR Labs conducted the studies with the assistance of independent U.S. board-certified neuroradiologists, and we reported the results in the format FDA expects. - **Wrote the 510(k) end to end in Medtech OS.** Device description, substantial equivalence, software and risk documentation, and a full cybersecurity file with an SBOM, static analysis and DICOM fuzz testing. - **Used every FDA touchpoint.** We requested an early orientation meeting, so the review team saw a live NeuroDR demonstration before opening the documentation. - **Turned FDA\'s questions around fast.** When FDA asked for more information, we had a response plan to the client within days and the response back to FDA soon after. ### The Innolitics Team - **Yujan Shrestha, MD, Partner,** set the regulatory strategy, including the call to skip the Pre-Sub. - **Cooper Molloy** led the project, submitted the eSTAR and ran the FDA review. - **Meri Martinez** led the regulatory strategy phase, **Mary Vater** provided regulatory leadership, and **Ilya Spivakov** handled cybersecurity. ### Celebrating the Win Innolitics is writing and sponsoring a joint press release with Deep Reasoning AI to announce the clearance. When you share your story with us in a case study like this one, Innolitics sponsors and coordinates a joint press release celebrating your success. ### About [Deep Reasoning AI](https://deepreasoningai.com/) - [Deep Reasoning AI](https://deepreasoningai.com/), based in Sarasota, Florida, builds patient-specific 3D anatomical models from CT, X-ray and MRI scans. Its leadership includes Cornell University professors Bart Selman, PhD (Chairman) and Carla P. Gomes, PhD (CTO). Mayo Clinic is a collaborator and shareholder. - NeuroDR was developed in collaboration with 3DR Labs of Louisville, Kentucky, which provides 3D imaging post-processing and AI imaging services to hospitals nationwide.