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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 / March 2026 / K253950

510(k) cleared

Avatar Medical Vision

Avatar Medical · Mar 30, 2026 · K253950

FDA cleared the Avatar Medical Vision from Avatar Medical on Mar 30, 2026 under K253950, 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 Dec 10, 2025. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Avatar Medical has one other decision in the tracker over the last 12 months: K252665 (brAIn Shoulder Positioning).

Questions & Answers

What did FDA clear under K253950?

K253950 is the FDA 510(k) for Avatar Medical Vision, submitted by Avatar Medical. FDA's decision date was Mar 30, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Avatar Medical Vision?

Avatar Medical, based in Paris, is the applicant of record for K253950.

How long did the K253950 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Mar 30, 2026, 110 days later.

← All decisions in March 2026

Sources