K090466 is an FDA 510(k) clearance for the DIGITAL RETINAL CAMERA, CR-1 MARK II. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Canon, Inc. (Lake Success, US). The FDA issued a Cleared decision on March 23, 2009, 30 days after receiving the submission on February 21, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K090466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2009 |
| Decision Date | March 23, 2009 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| 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 |