510(k) DEN180005 ยท QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
OsteoDetect
| Applicant | Imagen Technologies, Inc., New York NY, US |
| Decision | Unknown, May 24, 2018 |
| Received | Feb 5, 2018 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN180005
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.