K261378
- 510(k) number
- K261378
- Device name
- Rayvolve AZchest
- Applicant
- AZmed FR
- Product code
- QBS — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-08-28
- Date received
- 2026-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K261378.pdf
Official FDA record: K261378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.