510(k) K190457 ยท KPS System, Tomography, Computed, Emission
VERITON CT whole body SPECT/CT system
| Applicant | Spectrum Dynamics Medical, Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Jul 12, 2019 |
| Received | Feb 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190457
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.