The following data is part of a premarket notification filed by Nidek Co., Ltd with the FDA for Image Filing Software Navis-ex.
| Device ID | K181345 |
| 510k Number | K181345 |
| Device Name: | Image Filing Software NAVIS-EX |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Nidek Co., Ltd 34-14 Maehama Hiroishi-cho Gamagori, JP 443-0038 |
| Contact | Yoneji Mizuno |
| Correspondent | Enrico Bisson Nidek Technologies Srl Via Dell'Artigianato, 6/A Albignasego (padova), IT 35020 |
| Product Code | NFJ |
| Subsequent Product Code | HJO |
| Subsequent Product Code | HKI |
| Subsequent Product Code | IYO |
| Subsequent Product Code | NFF |
| Subsequent Product Code | NFG |
| Subsequent Product Code | NQE |
| Subsequent Product Code | OBO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2018-07-19 |
| Summary: | summary |