510(k) K191582 ยท KPS System, Tomography, Computed, Emission
Cartesion Prime
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Aug 13, 2019 |
| Received | Jun 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191582
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.