Cleared Traditional

IMAGEnet 6 Ophthalmic Data System

K171370 · Topcon Corporation · Ophthalmic
Nov 2017
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K171370 is an FDA 510(k) clearance for the IMAGEnet 6 Ophthalmic Data System, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 1, 2017, 175 days after receiving the submission on May 10, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K171370 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2017
Decision Date November 01, 2017
Days to Decision 175 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