510(k) K183182 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
Critical Care Suite
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 12, 2019 |
| Received | Nov 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183182
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.