FDA.reportPublic FDA data

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000

Primary DI
04562123288261
Brand
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
Company
TOPCON CORPORATION
Model
3D OCT-2000
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OBOTomography, optical coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBOTomography, Optical CoherenceOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562123288261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562123288261045621232882614562123288261

GMDN Terms#

Term, Definition table
TermDefinition
Retinal optical coherence tomography systemAn assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690542881
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04562123288315SPECULAR MICROSCOPE SP-1PSP-1P2016-09-19
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000MC-5S2025-12-09
04560126269188AUTO KERATO-REFRACTOMETER KR-1KR-12025-11-21
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATRK-32025-11-17
04560126269140AUTO KERATO-REFRACTOMETER KR-800KR-8002025-10-31
04560126269164AUTO REFRACTOMETER RM-800RM-8002025-10-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)3D OCT-12025-09-11
04571130283381AUTO KERATO-REFRACTOMETER KR-1KR-12025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PAKR-800PA2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosSNi-12025-05-01
04560126268495SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000SNi-12025-02-27
04571130283367AUTO KERATO-REFRACTOMETER KR-800AKR-800A2025-04-15
04562123288179COMPUTERIZED TONOMETER CT-80CT-802016-09-19
04560126268532COMPU VISION CV-5000CV-50002025-02-27
04560126268549COMPU VISION CV-5000CV-50002025-02-27
045601262685701DIAL CONTROLLER KB-50SKB-50S2025-02-27
04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04560126268648POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04571130282773REFRACTION SYSTEM ChronosChronos2024-08-01
04571130283350AUTO KERATO-REFRACTOMETER KR-800KR-8002024-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
04059237000723SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
00857691006039ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2024-05-02
04059237000938ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04059237000945ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.OBO2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.OBO2023-06-12
04582273604704Cornea/Anterior Segment OCTTOMEY CORPORATION.OBO2023-06-07
04059237000884SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000877ANTERIONHeidelberg Engineering GmbHOBO2022-09-29
04059237000754ANTERIONHeidelberg Engineering GmbHOBO2022-02-14
04059237000815SPECTRALISHeidelberg Engineering GmbHOBO2022-02-02
04059237000839SPECTRALISHeidelberg Engineering GmbHOBO2022-02-02
045711302829573D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2022-01-28
04059237000617ANTERIONHeidelberg Engineering GmbHOBO2022-01-03
03615020000496ANAEYES OCT for system linkageESSILOR INTERNATIONALOBO2021-02-18
04571130282186ANTERIOR ATTACHMENT HA-2TOPCON CORPORATIONOBO2021-02-03
04571130282193ANTERIOR SEGMENT ATTACHMENT KIT AA-1TOPCON CORPORATIONOBO2021-01-15
00850003069302IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-12-09
00857691006374ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2020-11-19
00858848006766iFusionOPTOVUE, INC.OBO2020-08-24
00850003069241IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-06-23
00857691006367ENVISU C2300 VHR 100VBIOPTIGEN, INC.OBO2020-06-01