The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for Topcon 3d Oct-1000 Optical Coherence Tomography System For Measurement Of Retinal Thickness.
| Device ID | K072971 |
| 510k Number | K072971 |
| Device Name: | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS |
| Classification | Tomography, Optical Coherence |
| Applicant | TOPCON MEDICAL SYSTEMS, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan TOPCON MEDICAL SYSTEMS, INC. 555 THIRTEENTH ST., 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 | 2007-10-22 |
| Decision Date | 2009-01-13 |
| Summary: | summary |