The following data is part of a premarket notification filed by Canon, Inc. with the FDA for As-10.
| Device ID | K200887 |
| 510k Number | K200887 |
| Device Name: | AS-10 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Canon, Inc. 9-1 Imaikami-Cho, Nakahara-Ku Kawasaki, JP 211-8501 |
| Contact | Akira Hirai |
| Correspondent | Gregory Woodard Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson, TX 75081 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-02 |
| Decision Date | 2020-04-15 |