IMAGEnet6 Ophthalmic Data System— 510(k) K232828

Substantially Equivalent

Topcon Corporation

FDA 510(k) clearance K232828 for IMAGEnet6 Ophthalmic Data System, Substantially Equivalent on 2024-03-01. Applicant: Topcon Corporation.

Clearance details

Applicant: Topcon Corporation
Product code: Code NFJ
Advisory panel: Radiology
Date received: 2023-09-13
Decision date: 2024-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Itabashi-Ku, JP

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.