The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Xidf - Aws801, Angio Workstation (alphenix Workstation), V8.0.
| Device ID | K181415 |
| 510k Number | K181415 |
| Device Name: | XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Jannie F. Reyes Canon Medical Systems USA 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 | 2018-05-30 |
| Decision Date | 2018-09-10 |
| Summary: | summary |