510(k) K203314 ยท KPS System, Tomography, Computed, Emission
Cartesion Prime (PCD-1000A/3) V10.8
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Apr 23, 2021 |
| Received | Nov 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203314
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2020 | Canon Medical System, USA, INC. Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.