510(k) K211161 ยท QIH Automated Radiological Image Processing Software
Critical Care Suite with Endotracheal Tube Positing AI algorithm
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 29, 2021 |
| Received | Apr 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211161
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.