The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Topcon 3d Oct-1000 Optical Coherence Tomography System.
| Device ID | K063388 |
| 510k Number | K063388 |
| Device Name: | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM |
| Classification | Tomography, Optical Coherence |
| Applicant | TOPCON CORP. 555 THIRTEENTH STREET NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan TOPCON CORP. 555 THIRTEENTH STREET NW COLUMBIA SQUARE 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 | 2006-11-08 |
| Decision Date | 2007-06-22 |
| Summary: | summary |