510(k) K213566 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
ClearRead Xray Pneumothorax
| Applicant | Riverain Technologies, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Mar 10, 2022 |
| Received | Nov 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213566
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.