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AMA Optics Digital Vision Test

FDA UDI

Class I (US FDA UDI)

by AMA Optics, Inc.

Identity

Trade Name
AMA Optics Digital Vision Test FDA UDI
Generic Name
Vision self-testing software FDA UDI
Device Name
A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc. FDA UDI
Model / Reference
DiagnosticGame FDA UDI
Description
A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc. FDA UDI

Identifiers

Catalog Number
DG01 FDA UDI
Primary DI / UDI-DI
G506DG010 FDA UDI
FDA Product Code
QTO FDA UDI
GMDN Term
Vision self-testing software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1150 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vision self-testing software

AMA Optics Digital Vision Test by AMA Optics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vision self-testing software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AMA Optics, Inc.

Sources (1)

  • FDA UDI 16fbf74e-12d7-4f59-ab17-83805330f506 34 fields · synced May 30, 2026