The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Alphenix, Infx-8000v/b, /s, V9.1.
| Device ID | K203551 |
| 510k Number | K203551 |
| Device Name: | Alphenix, INFX-8000V/B, /S, V9.1 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins Canon Medical Systems USA, INC. 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-04 |
| Decision Date | 2020-12-18 |