510(k) K211846 ยท KPS System, Tomography, Computed, Emission
Discovery MI Gen2
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 20, 2021 |
| Received | Jun 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211846
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.