The following data is part of a premarket notification filed by Topcon Corporation with the FDA for Imagenet 6 Ophthalmic Data System.
| Device ID | K171370 |
| 510k Number | K171370 |
| Device Name: | IMAGEnet 6 Ophthalmic Data System |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Topcon Corporation 75-1 Hasunuma-Cho, Itabashi-Ku Tokyo, JP 174-8580 |
| Contact | James Lorkowski |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | NFJ |
| Subsequent Product Code | HKI |
| Subsequent Product Code | OBO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-10 |
| Decision Date | 2017-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003069050 | K171370 | 000 |
| 00850003069029 | K171370 | 000 |
| 00850003069005 | K171370 | 000 |
| 00850003069074 | K171370 | 000 |
| 04562123288582 | K171370 | 000 |