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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 / October 2025 / K251027

510(k) cleared

cvi42 Coronary Plaque Software Application

Circle Cardiovascular Imaging, Inc. · Oct 27, 2025 · K251027

FDA cleared the cvi42 Coronary Plaque Software Application from Circle Cardiovascular Imaging, Inc. on Oct 27, 2025 under K251027, 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 Apr 2, 2025. The decision came 208 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Circle Cardiovascular Imaging, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251027?

K251027 is the FDA 510(k) for cvi42 Coronary Plaque Software Application, submitted by Circle Cardiovascular Imaging, Inc.. FDA's decision date was Oct 27, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the cvi42 Coronary Plaque Software Application?

Circle Cardiovascular Imaging, Inc., based in Calgary, is the applicant of record for K251027.

How long did the K251027 review take?

FDA received the submission on Apr 2, 2025 and issued its decision on Oct 27, 2025, 208 days later.

← All decisions in October 2025