Cleared Traditional

IMAGEnet6 Ophthalmic Data System

K232828 · Topcon Corporation · Ophthalmic
Mar 2024
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K232828 is an FDA 510(k) clearance for the IMAGEnet6 Ophthalmic Data System, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Topcon Corporation (Itabashi-Ku, JP). The FDA issued a Cleared decision on March 1, 2024, 170 days after receiving the submission on September 13, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K232828 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2023
Decision Date March 01, 2024
Days to Decision 170 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