The following data is part of a premarket notification filed by Canon, Inc. with the FDA for As-10, Cxdi-401rf.
| Device ID | K171194 |
| 510k Number | K171194 |
| Device Name: | AS-10, CXDI-401RF |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Canon, Inc. 9-1, Imaikami-Cho,Nakahara-Ku Kawasaki, JP 211-8501 |
| Contact | Shinji Mori |
| Correspondent | Diane Rutherford Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson, TX 75080 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-05-24 |
| Summary: | summary |