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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 / June 2026 / K260576

510(k) cleared

MeVis AVM Contour

MeVis Medical Solutions AG · Jun 30, 2026 · K260576

FDA cleared the MeVis AVM Contour from MeVis Medical Solutions AG on Jun 30, 2026 under K260576, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 20, 2026. The decision came 130 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 MeVis Medical Solutions AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260576?

K260576 is the FDA 510(k) for MeVis AVM Contour, submitted by MeVis Medical Solutions AG. FDA's decision date was Jun 30, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the MeVis AVM Contour?

MeVis Medical Solutions AG, based in Bremen, is the applicant of record for K260576.

How long did the K260576 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Jun 30, 2026, 130 days later.

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