510(k) K223212 ยท KPS System, Tomography, Computed, Emission
Precision DL
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Apr 27, 2023 |
| Received | Oct 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223212
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.