K111612 is an FDA 510(k) clearance for the DIGITAL RETINAL CAMERA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Canon, Inc. (Honkomagome, Bunkyo-Ku Tokyo, JP). The FDA issued a Cleared decision on September 14, 2011, 97 days after receiving the submission on June 9, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K111612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2011 |
| Decision Date | September 14, 2011 |
| Days to Decision | 97 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI — Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |