The following data is part of a premarket notification filed by Topcon Corporation with the FDA for Dri Oct Triton.
| Device ID | K173119 |
| 510k Number | K173119 |
| Device Name: | DRI OCT Triton |
| Classification | Tomography, Optical Coherence |
| Applicant | Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, JP 174-8580 |
| Contact | Charles Reisman |
| Correspondent | Zvi Ladin Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 Dedham, MA 02026 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-01-19 |
| Summary: | summary |