The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Optical Coherence Tomography 3d Oct-2000.
| Device ID | K092470 |
| 510k Number | K092470 |
| Device Name: | OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 |
| Classification | Tomography, Optical Coherence |
| Applicant | TOPCON CORP. 75-1 HASUNUMA-CHO ITABASHI-KU Tokyo, JP 174 |
| Contact | Takao Sugawara |
| Correspondent | Takao Sugawara TOPCON CORP. 75-1 HASUNUMA-CHO ITABASHI-KU Tokyo, JP 174 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-12 |
| Decision Date | 2009-09-02 |
| Summary: | summary |