K123101 is an FDA 510(k) clearance for the TRC-50DX 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. (North Reading, US). The FDA issued a Cleared decision on June 5, 2013, 244 days after receiving the submission on October 4, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K123101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2012 |
| Decision Date | June 05, 2013 |
| Days to Decision | 244 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 |