The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for Trc-50dx Retinal Camera.
| Device ID | K123101 |
| 510k Number | K123101 |
| Device Name: | TRC-50DX RETINAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-04 |
| Decision Date | 2013-06-05 |
| Summary: | summary |