The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Digital Radiography, Model Cxdi-55c.
| Device ID | K091436 |
| 510k Number | K091436 |
| Device Name: | DIGITAL RADIOGRAPHY, MODEL CXDI-55C |
| 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 | Jeff 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 | 2009-05-14 |
| Decision Date | 2009-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04960999988184 | K091436 | 000 |