The following data is part of a premarket notification filed by Canon Inc. with the FDA for Canon Non-mydriatic Retinal Camera Cr Series.
| Device ID | K201122 |
| 510k Number | K201122 |
| Device Name: | Canon Non-mydriatic Retinal Camera CR Series |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki, JP 211-8501 |
| Contact | Akira Hirai |
| Correspondent | Akira Hirai Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki, JP 211-8501 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2020-07-23 |