K232526 is an FDA 510(k) clearance for the XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on September 12, 2023, 22 days after receiving the submission on August 21, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K232526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2023 |
| Decision Date | September 12, 2023 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |