510(k) K193417 ยท QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
FractureDetect (FX)
| Applicant | Imagen Technologies, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jul 30, 2020 |
| Received | Dec 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193417
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.