510(k) K201933 ยท KPS System, Tomography, Computed, Emission
ImagenSPECT 3.0
| Applicant | Cardiovascular Imaging Technologies, Kansas City MO, US |
| Decision | Substantially Equivalent, Aug 11, 2020 |
| Received | Jul 13, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201933
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.