K123460 is an FDA 510(k) clearance for the TRC-NW300 NON-MYDRIATIC RETINAL CAMERA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Topcon Medical Systems, Inc. (Oakland, US). The FDA issued a Cleared decision on February 6, 2013, 89 days after receiving the submission on November 9, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K123460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2012 |
| Decision Date | February 06, 2013 |
| Days to Decision | 89 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 |