Topcon Medical Systems, Inc.
Topcon Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2018, with 3 FDA device recalls on record.
Top product codes for Topcon Medical Systems, Inc.
FDA recalls by Topcon Medical Systems, Inc.
- Z-0362-2025 — The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.
- Z-0952-2021 — Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.
- Z-1138-2019 — IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of any medical devices or through computerized networks.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Topcon Medical Systems, Inc.
- K182376 — Harmony
- K151952 — Synergy ODM
- K132438 — IMAGENET 5 PC SOFTWARE SYSTEM
- K132667 — SYNERGY ODM
- K123101 — TRC-50DX RETINAL CAMERA
- K123460 — TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
- K110489 — SLIT LAMP SL-2G
- K093313 — SYNERGY
- K083316 — 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
- K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
- K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.