510(k) K260378 ยท QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Rayvolve
| Applicant | AZmed, Paris, FR |
| Decision | Substantially Equivalent, May 12, 2026 |
| Received | Feb 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260378
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.