Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K251602) with a decision date of 2025-10-10. Review panel: Radiology.
| FDA submission number | K251602 |
|---|---|
| Pathway | 510(k) |
| Company | Canon Medical Systems Corporation |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-10-10 |
| Decision | Substantially Equivalent |
| Product code | OWB |
| Classification | Interventional Fluoroscopic X-Ray System |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 136 |
| 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.