Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of TopconLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Topcon Medical Systems with 11 510(k) clearances and 3 device recalls. The most recent is a device recall dated Sep 17, 2024: The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 17, 2024 | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital iClass II · The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Repo | Device recalls |
| Dec 18, 2020 | Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionaClass II · Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patien | Device recalls |
| Mar 6, 2019 | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and managemeClass II · When a patient is selected in the patient data and another patient is selected prior to the display of the primary patie | Device recalls |
| Sep 28, 2018 | HarmonyK182376 · NFJ | 510(k) clearances |
| Oct 1, 2015 | Synergy ODMK151952 · NFJ | 510(k) clearances |
| Oct 17, 2013 | IMAGENET 5 PC SOFTWARE SYSTEMK132438 · NFJ | 510(k) clearances |
| Oct 9, 2013 | SYNERGY ODMK132667 · NFJ | 510(k) clearances |
| Jun 5, 2013 | TRC-50DX RETINAL CAMERAK123101 · HKI | 510(k) clearances |
| Feb 6, 2013 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERAK123460 · HKI | 510(k) clearances |
| May 23, 2011 | SLIT LAMP SL-2GK110489 · HJO | 510(k) clearances |
| Dec 2, 2009 | SYNERGYK093313 · NFJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
