The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Digital Retinal Camera.
| Device ID | K111612 |
| 510k Number | K111612 |
| Device Name: | DIGITAL RETINAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON, INC. TOKYO OFFICE 6-5-3 BEAUNE HONKOMAGOME 2F Honkomagome, Bunkyo-ku Tokyo, JP 113-0021 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo CANON, INC. TOKYO OFFICE 6-5-3 BEAUNE HONKOMAGOME 2F Honkomagome, Bunkyo-ku Tokyo, JP 113-0021 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-09 |
| Decision Date | 2011-09-14 |
| Summary: | summary |