IMAGEnet 6

GUDID 00850003069166

The IMAGEnet 6 ver. 2.2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.

TOPCON HEALTHCARE SOLUTIONS, INC.

Camera application software
Primary Device ID00850003069166
NIH Device Record Key13a160ce-437b-4322-bcac-b64d8e68ebc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGEnet 6
Version Model Number2.2.0
Company DUNS081155097
Company NameTOPCON HEALTHCARE SOLUTIONS, INC.
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 Batchfalse
Serial Numberfalse
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
GS100850003069166 [Primary]

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-27
Device Publish Date2019-09-19

On-Brand Devices [IMAGEnet 6]

00850003069050The IMAGEnet 6 ver. 2.0.3 is a software program that is intended for use in the collection, stor
00850003069029The IMAGEnet 6 ver. 2.0.2 is a software program that is intended for use in the collection, stor
00850003069005The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the collection, storag
00850003069074The IMAGEnet 6 ver. 2.1.0 is a software program that is intended for use in the collection, stor
00850003069142The IMAGEnet 6 ver. 2.1.1 is a software program that is intended for use in the collection, stor
00850003069203The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection, stor
00850003069166The IMAGEnet 6 ver. 2.2.0 is a software program that is intended for use in the collection, stor
00850003069241The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the collection, stor
00850003069302The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, stor

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