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The Tracker / August 2026 / K261378

510(k) cleared

Rayvolve AZchest

AZmed · Aug 28, 2026 · K261378

FDA cleared the Rayvolve AZchest from AZmed on Aug 28, 2026 under K261378, 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 Apr 27, 2026. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

AZmed has one other decision in the tracker over the last 12 months: K260378 (Rayvolve).

Questions & Answers

What did FDA clear under K261378?

K261378 is the FDA 510(k) for Rayvolve AZchest, submitted by AZmed. FDA's decision date was Aug 28, 2026, under product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).

Who makes the Rayvolve AZchest?

AZmed, based in Paris, is the applicant of record for K261378.

How long did the K261378 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Aug 28, 2026, 123 days later.

← All decisions in August 2026

Sources