Vision self-testing software

Definition
A 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.
GUDID devices
5
Last updated
2025-02-11 14:54:52

Related Product Codes

CodeDeviceSpecialtyClassDevices
QTWDigital Amsler GridOphthalmic13
HOQGrid, AmslerOphthalmic11
QTODigital Visual Acuity TestOphthalmic11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00860003376102myVisionTrackBrightinsight, Inc.12024-01-09
00860003376119myVisionTrackBrightinsight, Inc.12024-01-09
00860003376157myVisionTrackBrightinsight, Inc.12024-01-09
G506DG010AMA Optics Digital Vision TestAMA Optics, Inc.DiagnosticGame2023-08-01
EOMA32120AlleyeOCULOCARE medical AG3.2.122023-05-15