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IMAGEnet 6

FDA UDI

Class II (US FDA UDI)

by Topcon Healthcare Solutions, Inc.

Identity

Trade Name
IMAGEnet 6 FDA UDI
Generic Name
Camera application software FDA UDI
Device Name
The IMAGEnet 6 ver. 2.4.0 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. FDA UDI
Model / Reference
2.4.0 FDA UDI
Description
The IMAGEnet 6 ver. 2.4.0 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00850003069302 FDA UDI
FDA Product Code
OBO FDA UDI
HKI FDA UDI
NFJ FDA UDI
GMDN Term
Camera application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1570 FDA UDI
886.1120 FDA UDI
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Camera application software

IMAGEnet 6 by Topcon Healthcare Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Camera application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Topcon Healthcare Solutions, Inc.

Sources (1)

  • FDA UDI 649cb140-0a74-4424-8b34-ebf5e75e01cd 33 fields · synced May 30, 2026