FDA.reportPublic FDA data

myVisionTrack

Primary DI
00860003376119
Brand
myVisionTrack
Company
Brightinsight, Inc.
Model
1
Device description
Vision testing application - HCP Portal
Published
2024-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QTWDigital Amsler Grid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTWDigital Amsler GridOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003376119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003376119008600033761198600033761190860003376119

GMDN Terms#

Term, Definition table
TermDefinition
Vision self-testing softwareA software as a medical device (SaMD) application intended to be used by a patient for self-testing of visual function under consultation of a clinician (e.g., ophthalmologist). It provides on-screen images (e.g., shapes) whereby visual function can be tested over time (e.g., to monitor macular degeneration). It is intended to store and allow communication of the results with healthcare professionals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080811955
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003376102myVisionTrack12024-01-09
00860003376157myVisionTrack12024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003376102myVisionTrackBrightinsight, Inc.QTW2024-01-09
00860003376157myVisionTrackBrightinsight, Inc.QTW2024-01-09