FDA.reportPublic FDA data

External ocular measurement camera

Definition
A hand-held, battery-powered, optical device intended for digital image capture and analysis of the external ocular anatomy to assist in the diagnosis of ophthalmic abnormalities (e.g., ptosis, strabismus, glaucoma); it is not intended to capture images of the fundus. It consists of a digital camera which includes software intended to take specific ocular measurements (e.g., pupil diameter, horizontal visible iris diameter, margin reflex difference, interpupillary distance, strabismus angle).
GUDID devices
28
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B430GCKNOK4630GoCheck KidsGobiquity, Inc.Nokia 4.6.32017-06-06
B43060030010GoCheck KidsGobiquity, Inc.V5 i7 PFC2023-07-06
B43071000010GoCheck KidsGobiquity, Inc.V5 i15 PFC2024-07-26
B43071000030GoCheck MultiScreenerGobiquity, Inc.i15 Pro2025-11-19
B43071000020GoCheck MultiScreenerGobiquity, Inc.i7 Plus2024-09-23
B43050085440GoCheck KidsGobiquity, Inc.Mobile Application Version 5.4.42024-07-26
B430GCKIOS5430GoCheck KidsGobiquity, Inc.iPhone 5.4.32023-06-15
04260184512119plusoptiX 12Plusoptix GmbHA12C2022-10-20
04260184512218plusoptiX 12Plusoptix GmbHS12C2022-10-20
04260184513116plusoptiX 12Plusoptix GmbHA12R2022-10-20
04260184513215plusoptiX 12Plusoptix GmbHS12R2022-10-20
04260184514113plusoptiX 16Plusoptix GmbHA162022-10-20
04260184514212plusoptiX 16Plusoptix GmbHS162022-10-20
06970990160104MicroclearSuzhou Microclear Medical Instruments Co., Ltd.VS2021-01-27
06970990160111MicroclearSuzhou Microclear Medical Instruments Co., Ltd.VS-Pro2021-01-27
06970990160128MicroclearSuzhou Microclear Medical Instruments Co., Ltd.VS-Plus2021-01-27
06970990160135MicroclearSuzhou Microclear Medical Instruments Co., Ltd.VS-T2021-01-27
06970990160142MicroclearSuzhou Microclear Medical Instruments Co., Ltd.VS-T Pro2021-01-27
06970990160159MicroclearSuzhou Microclear Medical Instruments Co., Ltd.VS-T Plus2021-01-27
B430GCKNOK44290LGoCheck KidsGobiquity, Inc.Nokia 4.4.292017-02-11
B430GCKNOK44360GoCheck KidsGobiquity, Inc.Nokia 4.4.362016-12-30
B430GCKNOK44600GoCheck KidsGobiquity, Inc.Nokia 4.4.602017-02-27
00850938007004PanoCam™ LTVISUNEX MEDICAL SYSTEMS INC.PNLT-10-10-112016-09-24
00850938007011PanoCam™ PRO VISUNEX MEDICAL SYSTEMS INC.PNPR-11-10-112016-09-24
00850938007028PanoCam™ PROVISUNEX MEDICAL SYSTEMS INC.PNPR-11-10-232017-08-31
00850938007035PanoCam™ LTVISUNEX MEDICAL SYSTEMS INC.PNLT-10-10-232017-08-31
00850938007042PanoCam™ SOLOVISUNEX MEDICAL SYSTEMS INC.PanoCam™ SOLO2018-02-01
00864218000104iScreen VisionISCREEN VISION, INC.iScreen Vision Screener 30002016-09-23