The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for Imagenet 5 Pc Software System.
| Device ID | K132438 |
| 510k Number | K132438 |
| Device Name: | IMAGENET 5 PC SOFTWARE SYSTEM |
| Classification | System, Image Management, Ophthalmic |
| Applicant | TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-05 |
| Decision Date | 2013-10-17 |