510(k) K231748 ยท KPS System, Tomography, Computed, Emission
Cartesion Prime (PCD-1000A/3) V10.15
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Sep 12, 2023 |
| Received | Jun 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231748
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2024 | Canon Medical System, USA, INC. Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.