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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 / K260378

510(k) cleared

Rayvolve

AZmed · May 12, 2026 · K260378

FDA cleared the Rayvolve from AZmed on May 12, 2026 under K260378, a traditional 510(k). The device falls under product code QBS, Radiological Computer Assisted Detection/Diagnosis Software For Fracture, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 5, 2026. The decision came 96 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 AZmed in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260378?

K260378 is the FDA 510(k) for Rayvolve, submitted by AZmed. FDA's decision date was May 12, 2026, under product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).

Who makes the Rayvolve?

AZmed, based in Paris, is the applicant of record for K260378.

How long did the K260378 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on May 12, 2026, 96 days later.

← All decisions in May 2026