The following data is part of a premarket notification filed by Canon Inc. with the FDA for Digital Radiography Cxdi-60c.
| Device ID | K091545 |
| 510k Number | K091545 |
| Device Name: | DIGITAL RADIOGRAPHY CXDI-60C |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CANON INC. ONE CANON PLAZA Lake Success, NY 11042 |
| Contact | Sheila Driscoll |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-27 |
| Decision Date | 2009-06-15 |
| Summary: | summary |