510(k) K181343 ยท KPS System, Tomography, Computed, Emission
HeartSee Cardiac P.E.T. Processing Software
| Applicant | Bracco Diagnostics, Inc., Monroe Township NE, US |
| Decision | Substantially Equivalent, Jun 12, 2018 |
| Received | May 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181343
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.