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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 / K252665

510(k) cleared

brAIn Shoulder Positioning

Avatar Medical · Oct 20, 2025 · K252665

FDA cleared the brAIn Shoulder Positioning from Avatar Medical on Oct 20, 2025 under K252665, 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 Aug 25, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Avatar Medical has one other decision in the tracker over the last 12 months: K253950 (Avatar Medical Vision).

Questions & Answers

What did FDA clear under K252665?

K252665 is the FDA 510(k) for brAIn Shoulder Positioning, submitted by Avatar Medical. FDA's decision date was Oct 20, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the brAIn Shoulder Positioning?

Avatar Medical, based in Paris, is the applicant of record for K252665.

How long did the K252665 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Oct 20, 2025, 56 days later.

← All decisions in October 2025

Sources