510(k) K261378 ยท QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Rayvolve AZchest
| Applicant | AZmed, Paris, FR |
| Decision | Substantially Equivalent, Aug 28, 2026 |
| Received | Apr 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261378
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.