The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon X-ray Digital Camera, Model Cxdi-31.
| Device ID | K003689 |
| 510k Number | K003689 |
| Device Name: | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 |
| Classification | System, Imaging, X-ray, Electrostatic |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Sheila Driscoll |
| Correspondent | Sheila Driscoll CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | IXK |
| CFR Regulation Number | 892.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-30 |
| Decision Date | 2002-01-02 |