Home / Companies / Topcon Medical Systems, Inc.

Topcon Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0362-2025Class IIThe IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collectiSeptember 17, 2024
Z-0952-2021Class IIHarmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to bDecember 18, 2020
Z-1138-2019Class IIIMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for useMarch 6, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K182376HarmonySeptember 28, 2018
K151952Synergy ODMOctober 1, 2015
K132438IMAGENET 5 PC SOFTWARE SYSTEMOctober 17, 2013
K132667SYNERGY ODMOctober 9, 2013
K123101TRC-50DX RETINAL CAMERAJune 5, 2013
K123460TRC-NW300 NON-MYDRIATIC RETINAL CAMERAFebruary 6, 2013
K110489SLIT LAMP SL-2GMay 23, 2011
K093313SYNERGYDecember 2, 2009
K0833163D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEMMarch 13, 2009
K072971TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESSJanuary 13, 2009
K031831TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMDecember 19, 2003