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Glaucoma Module

FDA UDI

Class II (US FDA UDI)

by Topcon Healthcare Solutions, Inc.

Identity

Trade Name
Glaucoma Module FDA UDI
Generic Name
Camera application software FDA UDI
Device Name
Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coherence tomography data. FDA UDI
Model / Reference
1.00 FDA UDI
Description
Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coherence tomography data. FDA UDI

Identifiers

Primary DI / UDI-DI
00850003069135 FDA UDI
510(k) Number
K200954 FDA UDI
FDA Product Code
NFJ FDA UDI
GMDN Term
Camera application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

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

Glaucoma Module 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 cb65653e-24e0-4531-8f37-cbc1d695de49 34 fields · synced May 30, 2026