Rayvolve— 510(k) K260378
Substantially EquivalentAZmed
FDA 510(k) clearance K260378 for Rayvolve, Substantially Equivalent on 2026-05-12. Applicant: AZmed. Device class: 2.
Summary
AZmed's Rayvolve is filed under QBS, radiological computer assisted detection/diagnosis software for fracture.
Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
AZmed filed from Paris, France. The decision came 96 calendar days after receipt (February 5 to May 12, 2026).
Clearance details
- Applicant
- AZmed
- Product code
- Product code QBS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paris, FR
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