Cleared Traditional

Image Filing Software NAVIS-EX

K181345 · Nidek Co., Ltd. · Ophthalmic
Jul 2018
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K181345 is an FDA 510(k) clearance for the Image Filing Software NAVIS-EX, 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 review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K181345 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NFJ — System, Image Management, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050