The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Digital Radiography Cxdi-710c Wireless, Digital Radiography Cxdi-810c Wireless.
| Device ID | K170332 |
| 510k Number | K170332 |
| Device Name: | DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| 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 | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-02 |
| Decision Date | 2017-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292099454 | K170332 | 000 |
| 04549292099447 | K170332 | 000 |