510(k) K223491 ยท QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, May 25, 2023 |
| Received | Nov 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223491
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.