Topcon Healthcare, Inc.

Oakland, NJ, US

Topcon Healthcare, Inc. appears in FDA device records in Oakland, NJ. FDA records list 11 510(k) clearances between 2003-12-19 and 2018-09-28, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 11
PMA records: 0
Recall records: 3
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Topcon Healthcare, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Topcon Medical Systems, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 11 510(k) clearances for Topcon Healthcare, Inc. between 2003 and 2018. The busiest year on record is 2013, with 4. The most recent is 2018, with 1.

Clearances by year, as a table

510(k) clearance decisions for Topcon Healthcare, Inc., by decision year
Year	Clearances
2003	1
2009	3
2011	1
2013	4
2015	1
2018	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K182376	Harmony	NFJ	Substantially Equivalent	2018-09-28
K151952	Synergy ODM	NFJ	Substantially Equivalent	2015-10-01
K132438	IMAGENET 5 PC SOFTWARE SYSTEM	NFJ	Substantially Equivalent	2013-10-17
K132667	SYNERGY ODM	NFJ	Substantially Equivalent	2013-10-09
K123101	TRC-50DX RETINAL CAMERA	HKI	Substantially Equivalent	2013-06-05
K123460	TRC-NW300 NON-MYDRIATIC RETINAL CAMERA	HKI	Substantially Equivalent	2013-02-06
K110489	SLIT LAMP SL-2G	HJO	Substantially Equivalent	2011-05-23
K093313	SYNERGY	NFJ	Substantially Equivalent	2009-12-02
K083316	3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM	OBO	Substantially Equivalent	2009-03-13
K072971	TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS	OBO	Substantially Equivalent	2009-01-13
K031831	TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM	HKO	Substantially Equivalent	2003-12-19

Registered establishments

FDA registered establishments for Topcon Healthcare, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2242863	2242863	Topcon Healthcare, Inc.	111 Bauer Dr, Oakland, NJ 07436 US	2026	HJO HKI HKN HKO HKX HMD HME HMF HOS HOX and 6 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
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.	The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided	Class II	2024-09-17	Open, Classified
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.	Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record	Class II	2020-12-18	Terminated
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.	When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used.	Class II	2019-03-06	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain