510(k) K211247 ยท KPS System, Tomography, Computed, Emission
PET VCAR
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Jul 27, 2021 |
| Received | Apr 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211247
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.