The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Cxdi-40ec.
| Device ID | K062221 |
| 510k Number | K062221 |
| Device Name: | CXDI-40EC |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CANON, INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Sheila Driscoll |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-08-17 |
| Summary: | summary |