510(k) K171303 ยท KPS System, Tomography, Computed, Emission
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
| Applicant | University of Texas Medical School AT Houston, Texas, Houston TX, US |
| Decision | Substantially Equivalent, Sep 22, 2017 |
| Received | May 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171303
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.