Topcon Yamagata Co., LTD

FDA Device Registration & Listing · Yamagata-KEN, JP · Registration 3008729548

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008729548
FEI Number
3008729548
Entity Name
Topcon Yamagata Co., LTD
City/State/Country
Yamagata-KEN, JP
Establishment Address
547 aza Ishida Oaza Urushiyama Yamagata-SHI, Yamagata-KEN 990-2196, JP
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Topcon Healthcare, Inc. (Owner Number: 9031569)
Owner / Operator Contact Address
111 Bauer Drive, Oakland, NJ 07436, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

3D OCT-1(type: Maestro2) DRI OCT Triton Plus 3D OCT-2000 FA DRI OCT-1 Model Triton Plus 3D OCT-2000 (50k) DRI OCT Triton 3D OCT-2000 FA plus 3D OCT-1 Maestro DRI OCT-1 Model Triton 3D OCT-1 (Type:Maestro2) DRI OCT Triton2 SP-3000P TRC-50DX IMAGEnet6 TRK-3 OMNIA LM-8; LM-8E; CL-200; EZ-200 CL-300 IMAGEnet 6 TRC-NW400 3D OCT-1 Maestro CT-800 CT-1P CT-1 TRK-1P TRK-2P CT-800A TRK-3 OMNIA VT-10 CV-5000 3D OCT-1 Maestro 3D OCT-1 (Type:Maestro2) SS-3 MC-4S MIRROR CHART MC-5S PC-50S ACP-8 ACP-8R NW500 OMS-90 OMS-710 OMS-800 SP-1P SL-D301 3D OCT-2000 3D OCT-1000 SL-2G IMAGEnet R4 TRC-NW8F plus CT-80 TRC-NW300 IMAGEnet 6 IMAGEnet 7 OM-4 TRC-NW7SF MARK II

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2024-04-11
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2024-04-11
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2016-06-17
NQE Microscope, Specular Ophthalmic Class 2 886.1850 2016-06-17
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-06-17
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2024-03-21
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2024-03-21
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2024-03-21
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2025-11-14
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2025-11-14
HLM Instrument, Measuring, Lens, Ac-Powered Ophthalmic Class 1 886.1425 2003-10-06
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2017-11-02
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2017-11-02
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2017-11-02
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2014-10-27
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2016-07-29
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2016-07-29
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2016-06-17
HKN Refractor, Manual, Non-Powered, Including Phoropter Ophthalmic Class 1 886.1770 2003-10-06
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2017-03-06
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2017-03-06
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2011-11-22
HOS Projector, Ophthalmic Ophthalmic Class 1 886.1680 2003-10-06
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2022-08-31
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2003-10-06
NQE Microscope, Specular Ophthalmic Class 2 886.1850 2015-06-01
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2016-12-09
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2009-11-04
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2009-11-19
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2011-11-22
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2009-01-22
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2014-10-27
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2008-10-21
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-03-01
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2017-01-24
HJB Instrument, Measuring, Corneal Radius Ophthalmic Class 1 886.1450 2003-10-06
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2009-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

Susan Quick Business: Topcon Healthcare, Inc. Email: tmsregulatory@topcon.com Phone: (216) 7805532

Related Public Records

Same Entity

Topcon Healthcare, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3002808383 Topcon Yamagata Co., LTD West Factory Yamagata-ken, JP
2242863 Topcon Healthcare, Inc. Oakland, NJ, US
9614661 TOPCON CORP. TOKYO, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K041546 Canon, Inc. DIGITAL FUNDUS CAMERA, MODEL CF-60DSI 2004-06-23
K870750 Keeler Instruments, Inc. KEELER PULSAIR NON CONTACT TONOMETER 1987-03-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2018 Optovue, Inc. 2
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
Z-0024-2013 Optovue Inc. 2
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

Similar Registrations

Registration Number Establishment Name Location
3007237389 FUNDUS PHOTO Saint Louis, MO, US
3017175640 PHELCOM TECHNOLOGIES Sao Carlos Sao Paulo, BR
2936921 NIDEK INCORPORATED The Colony, TX, US
3010000450 CRYSTALVUE MEDICAL CORPORATION Taoyuan Dist.,, TW
9614661 TOPCON CORP. TOKYO, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008729548. Last updated year: 2026. Please use registration number 3008729548 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.