510(k) K243881 · KPS System, Tomography, Computed, Emission
HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
| Applicant | Bracco Diagnostics, Inc., Princeton NJ, US |
| Decision | Substantially Equivalent, Mar 3, 2025 |
| Received | Dec 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243881
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.