510(k) clearance
Rayvolve AZchest
- 510(k) number
- K261378
- Applicant
- AZmed
- Decision date
- Aug 28, 2026
- Date received
- Apr 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QBS
- Device type
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- Device class
- Class II
- Regulation
- 21 CFR 892.2090
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Paris, FR