510(k) K180318 ยท KPS System, Tomography, Computed, Emission
PET Digital Gating
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 11, 2018 |
| Received | Feb 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180318
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.