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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 / May 2026 / K260324

510(k) cleared

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

Canon Medical Informatics, Inc. · May 22, 2026 · K260324

FDA cleared the Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning from Canon Medical Informatics, Inc. on May 22, 2026 under K260324, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 30, 2026. The decision came 112 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: K252217 (CT VScore+).

Questions & Answers

What did FDA clear under K260324?

K260324 is the FDA 510(k) for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning, submitted by Canon Medical Informatics, Inc.. FDA's decision date was May 22, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning?

Canon Medical Informatics, Inc., based in Minnetonka, MN, is the applicant of record for K260324.

How long did the K260324 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on May 22, 2026, 112 days later.

← All decisions in May 2026

Sources