K233107 is an FDA 510(k) clearance for the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5. 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 August 30, 2024, 338 days after receiving the submission on September 27, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K233107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | August 30, 2024 |
| Days to Decision | 338 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 |