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 | K222687 |
| 510k Number | K222687 |
| 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 | Mr. Akira Hirai |
| Correspondent | Ms. Saori Sawaki Ken Block Consulting LLC 800 E Campbell Road, Suite 202 Richardson, TX 75081 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-06 |
| Decision Date | 2022-09-29 |