The following data is part of a premarket notification filed by Canon Inc. with the FDA for Digital Radiography Cxdi-701c Wireless, Digital Radiography Cxdi-70ig Wireless, Digital Radiography Cxdi-801c Wireless,.
| Device ID | K131106 |
| 510k Number | K131106 |
| Device Name: | DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CANON INC. 1201 RICHARDSON DRIVE, SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford CANON INC. 1201 RICHARDSON DRIVE, SUITE 280 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 | 2013-04-19 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04960999999708 | K131106 | 000 |
| 04960999989600 | K131106 | 000 |