Rayvolve AZchest— 510(k) K261378

Name: FDA 510(k) clearance K261378
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Substantially Equivalent

AZmed

FDA 510(k) clearance K261378 for Rayvolve AZchest, Substantially Equivalent on 2026-08-28. Applicant: AZmed. Device class: 2.

Summary

AZmed's Rayvolve AZchest is filed under product code QBS, radiological computer assisted detection/diagnosis software for fracture. The record has no description beyond the name and that code name.

Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

AZmed filed from Paris, France. The substantially equivalent decision came 123 calendar days after receipt (April 27 to August 28, 2026).

Clearance details

Applicant: AZmed
Product code: Product code QBS
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2026-04-27
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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