K251602 is an FDA 510(k) clearance for the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on October 10, 2025, 136 days after receiving the submission on May 27, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K251602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2025 |
| Decision Date | October 10, 2025 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |