FDA.reportPublic FDA data

IMAGEnet 6 OPHTHALMIC DATA SYSTEM

Primary DI
04562123288582
Brand
IMAGEnet 6 OPHTHALMIC DATA SYSTEM
Company
TOPCON CORPORATION
Model
IMAGEnet 6
Published
2018-02-07
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
HKICamera, Ophthalmic, Ac-Powered
NFJSystem, image management, ophthalmic
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
NFJSystem, Image Management, OphthalmicRadiology2
OBOTomography, Optical CoherenceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171370000IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation2017-11-01NFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562123288582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562123288582045621232885824562123288582

GMDN Terms#

Term, Definition table
TermDefinition
Camera application softwareA data program designed for use in, or together with, a camera (e.g., a digital camera or video recorder) so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690542881
Device count
1
Lot or batch
true
Serial number
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

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00857253006033FA ModulePhoenix ClinicalHKI2026-04-03
00857253006071DiffuserPhoenix ClinicalHKI2026-04-03
00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
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06430046260689Smartscope Pro retinal setOptomed OyHKI2025-11-13
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
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08800019600794Huvitz Integrated Image Server HIIS-1Huvitz Co., Ltd.NFJ2025-08-14
06430078740272Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2025-08-07
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04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
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00850003069357HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
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