K181345 is an FDA 510(k) clearance for the Image Filing Software NAVIS-EX. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on July 19, 2018, 59 days after receiving the submission on May 21, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K181345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2018 |
| Decision Date | July 19, 2018 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NFJ — System, Image Management, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |