The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for 3d Oct-1000 Mark Ii Optical Coherence Tomography System.
| Device ID | K083316 |
| 510k Number | K083316 |
| Device Name: | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM |
| Classification | Tomography, Optical Coherence |
| Applicant | TOPCON MEDICAL SYSTEMS, INC. 310 TERRACE AVENUE SUITE 201 Cincinnati, OH 45220 |
| Contact | Barbara S Fant |
| Correspondent | Barbara S Fant TOPCON MEDICAL SYSTEMS, INC. 310 TERRACE AVENUE SUITE 201 Cincinnati, OH 45220 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-03-13 |
| Summary: | summary |