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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K252217

510(k) cleared

CT VScore+

Canon Medical Informatics, Inc. · Nov 28, 2025 · K252217

FDA cleared the CT VScore+ from Canon Medical Informatics, Inc. on Nov 28, 2025 under K252217, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 15, 2025. The decision came 136 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Canon Medical Informatics, Inc. has one other decision in the tracker over the last 12 months: K260324 (Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning).

Questions & Answers

What did FDA clear under K252217?

K252217 is the FDA 510(k) for CT VScore+, submitted by Canon Medical Informatics, Inc.. FDA's decision date was Nov 28, 2025, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the CT VScore+?

Canon Medical Informatics, Inc., based in Minnetonka, MN, is the applicant of record for K252217.

How long did the K252217 review take?

FDA received the submission on Jul 15, 2025 and issued its decision on Nov 28, 2025, 136 days later.

← All decisions in November 2025

Sources