Cartesion Prime (PCD-1000A/3) V10.21 is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K251370) with a decision date of 2025-12-01. Review panel: Radiology.
| FDA submission number | K251370 |
|---|---|
| Pathway | 510(k) |
| Company | Canon Medical Systems Corporation |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-12-01 |
| Decision | Substantially Equivalent |
| Product code | KPS |
| Classification | System, Tomography, Computed, Emission |
| Device class | 2 |
| Regulation number | 892.1200 |
| Review time (calendar days) | 213 |
| Applicant country | JP |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.