510(k) K202679 ยท KPS System, Tomography, Computed, Emission
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
| Applicant | Mcgovern Medical School, Houston TX, US |
| Decision | Substantially Equivalent, Apr 12, 2021 |
| Received | Sep 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202679
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.