510(k) K231731 ยท KPS System, Tomography, Computed, Emission
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
| Applicant | Mcgovern Medical School, Houston TX, US |
| Decision | Substantially Equivalent, Aug 21, 2023 |
| Received | Jun 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231731
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.