FDA.reportPublic FDA data

Vision/eye movement analysis system

Definition
An electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.
GUDID devices
35
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860002280707Vestibular FirstVestibular First, LLCInsight Infrared Video Goggles2020-11-17
03760253450027VT1FIM MEDICALDMV EDITION2017-10-16
03760253450140VT1FIM MEDICALMASTER GT EDITION2017-10-16
03760253450164VT1FIM MEDICALMASTER EDITION2017-10-16
03760253450171VT1FIM MEDICALMASTER EDITION with Remote control2017-10-17
03760253450225VT1FIM MEDICALLCD remote control2017-10-16
03760253450256VT1FIM MEDICALEssential remote control2017-10-16
05711117223538InteracousticsInteracoustics A/SVisualEyes 5052020-11-11
05711117223545InteracousticsInteracoustics A/SVisualEyes 5152020-11-11
05711117223552InteracousticsInteracoustics A/SVisualEyes 5252020-11-11
05711117223569InteracousticsInteracoustics A/SOrion Comprehensive Basic2020-11-11
05711117223576InteracousticsInteracoustics A/SOrion Autotraverse Basic2020-11-11
05711117223583InteracousticsInteracoustics A/SVisualEyes EyeSeeCam vHIT2020-11-11
08501830061107Micromedical TechnologiesMICROMEDICAL TECHNOLOGIES, INC.VisualEyes2016-09-24
08501830061114Micromedical TechnologiesMICROMEDICAL TECHNOLOGIES, INC.RealEyes2016-09-24
B818DX100Neurolign Dx100Spryson America, Inc.Dx1002020-07-01
B818NOTC0Neurolign Dx NOTCSpryson America, Inc.Dx NOTC2020-07-01
B818SVNG0Neurolign Dx SVNGSpryson America, Inc.Dx SVNG2020-07-01
00732094322385Welch Allyn, Inc.WELCH ALLYN, INC.9010292019-07-18
00732094246964Welch Allyn, Inc.WELCH ALLYN, INC.9011222020-03-19
00732094247039Welch Allyn, Inc.WELCH ALLYN, INC.9011222020-03-19
00732094248692Welch Allyn, Inc.WELCH ALLYN, INC.9011222020-03-19
00732094249125Welch Allyn, Inc.WELCH ALLYN, INC.9011222020-03-19
06945087510018MediWorksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.V1002019-04-04
05711117180558InteracousticsInteracoustics A/SVisualEyes 5252016-11-10
05711117195989InteracousticsInteracoustics A/SVisualEyes 5052017-06-15
00850514007107Diopsys®DIOPSYS, INC.2400-0025-002017-05-05
00868096000300EYE-SYNCNEUROSYNC INC.X022017-11-21
00732094088250Welch Allyn, Inc.WELCH ALLYN, INC.9010292017-12-05
00732094088267Welch Allyn, Inc.WELCH ALLYN, INC.9010292017-12-05
00732094088281Welch Allyn, Inc.WELCH ALLYN, INC.9010292017-12-05
00732094088427Welch Allyn, Inc.WELCH ALLYN, INC.9010292017-12-05
00732094088441Welch Allyn, Inc.WELCH ALLYN, INC.9010292017-12-05
00732094212228Welch Allyn, Inc.WELCH ALLYN, INC.9010292017-12-05
00732094212235Welch Allyn, Inc.WELCH ALLYN, INC.9010292017-12-05