K260378
- 510(k) number
- K260378
- Device name
- Rayvolve
- Applicant
- AZmed FR
- Product code
- QBS — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-05-12
- Date received
- 2026-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260378.pdf
Official FDA record: K260378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.