The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Alphenix, Infx-8000h/b, V8.0.
| Device ID | K182546 |
| 510k Number | K182546 |
| Device Name: | Alphenix, INFX-8000H/B, V8.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Janine F. Reyes Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-17 |
| Decision Date | 2018-10-17 |
| Summary: | summary |