IMAGEnet 6 OPHTHALMIC DATA SYSTEM

GUDID 04562123288582

TOPCON CORPORATION

Camera application software
Primary Device ID04562123288582
NIH Device Record Keyf00e9ec8-aad8-4bfc-9120-ce866193e983
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGEnet 6 OPHTHALMIC DATA SYSTEM
Version Model NumberIMAGEnet 6
Company DUNS690542881
Company NameTOPCON CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104562123288582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKICamera, Ophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-27
Device Publish Date2018-02-07

Devices Manufactured by TOPCON CORPORATION

04571130282773 - REFRACTION SYSTEM Chronos2024-08-09
04571130283350 - AUTO KERATO-REFRACTOMETER KR-8002024-05-17
04571130283374 - AUTO REFRACTOMETER RM-8002024-05-17
04562123288384 - COMPUTERIZED LENSMETER CL-3002023-12-27
04562123288391 - COMPUTERIZED LENSMETER CL-3002023-12-27
04560126268198 - Chinrest CRX-1000 for REFRACTION SYSTEM Chronos2023-11-24
04560126264640 - INFRARED COMMUNICATION UNIT2022-09-08
04560126266071 - KR-1W Viewer2022-09-08

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