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 Cxdi-11.
| Device ID | K981556 |
| 510k Number | K981556 |
| Device Name: | CANON X-RAY DIGITAL CAMERA CXDI-11 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Glenn Impal |
| Correspondent | Glenn Impal CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-01 |
| Decision Date | 1998-11-04 |
| Summary: | summary |