The following data is part of a premarket notification filed by Topcon Corporation with the FDA for 3d Oct-1 Maestro.
| Device ID | K161509 |
| 510k Number | K161509 |
| Device Name: | 3D OCT-1 Maestro |
| Classification | Tomography, Optical Coherence |
| Applicant | Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, JP 174-8580 |
| Contact | Charles Reisman |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-07-28 |
| Summary: | summary |