The following data is part of a premarket notification filed by Canon Inc. with the FDA for Digital Radiography Cxdi-elite, Digital Radiography E1.
| Device ID | K213780 |
| 510k Number | K213780 |
| Device Name: | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Canon Inc. 9-1 Imaikami-Cho, Nakahara-Ku Kawasaki, JP 211-8501 |
| Contact | Akira Hirai |
| Correspondent | Gregory Woodard Ken Block Consulting 800 East Campbell Drive, Suite 202 Richardson, TX 75081 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-02 |
| Decision Date | 2022-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292200942 | K213780 | 000 |