FDA.report

Electroretinograph

Definition
An ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorder is used with a primary electrode [typically gold (Au), platinum (Pt) or silver (Ag)] and a reference electrode located almost anywhere on the body, e.g., cheek or ear lobe, and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina.
GUDID devices
178
Last updated
2025-06-17 15:27:40

Related Product Codes

CodeDeviceSpecialtyClassDevices
GWEStimulator, Photic, Evoked ResponseNeurology2174
GXYElectrode, CutaneousNeurology22
HLGPupillometer, Ac-PoweredOphthalmic12
HGLTransducer, Ultrasonic, ObstetricObstetrics/Gynecology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00857901006347UTASL K C TECHNOLOGIES, INC.UTAS System Type-412020-11-18
00850594007004StandaloneDIAGNOSYS LLCD1752023-06-01
04260157780200RETI-port/scan 21 basicRoland Consult Stasche & Finger GmbH202023-02-26
04260157780217RETI-port/scan 21 alphaRoland Consult Stasche & Finger GmbH212023-02-26
04260157780224RETI-port/scan 21 alpha plusRoland Consult Stasche & Finger GmbH222023-02-26
04260157780231RETI-port/scan 21 betaRoland Consult Stasche & Finger GmbH232023-02-26
04260157780248RETI-port/scan 21 beta plusRoland Consult Stasche & Finger GmbH242023-02-26
04260157780255RETI-port/scan 21 gammaRoland Consult Stasche & Finger GmbH252023-02-26
04260157780262RETI-port/scan 21 gamma plusRoland Consult Stasche & Finger GmbH262023-02-26
04260157780279RETI-port/scan 21 gamma plus²Roland Consult Stasche & Finger GmbH272023-02-26
04260157780286RETI-port/scan 21 delta plusRoland Consult Stasche & Finger GmbH282023-02-26
00857901006491UTASL K C TECHNOLOGIES, INC.UTAS System Type-9L2022-06-27
00857901006507UTASL K C TECHNOLOGIES, INC.UTAS System Type-10L2022-06-27
00857901006514UTASL K C TECHNOLOGIES, INC.UTAS System Type-11L2022-06-27
00857901006521UTASL K C TECHNOLOGIES, INC.UTAS System Type-12L2022-06-27
00857901006538UTASL K C TECHNOLOGIES, INC.UTAS System Type-39L2022-06-27
00857901006545UTASL K C TECHNOLOGIES, INC.UTAS System Type-40L2022-06-27
00857901006552UTASL K C TECHNOLOGIES, INC.UTAS System Type-41L2022-06-27
00857901006569UTASL K C TECHNOLOGIES, INC.UTAS System Type-47L2022-06-27
00857901006576UTASL K C TECHNOLOGIES, INC.UTAS System Type-48L2022-06-27
00857901006583UTASL K C TECHNOLOGIES, INC.UTAS System Type-50L Pattern/Multifocal2022-06-27
00857901006590UTASL K C TECHNOLOGIES, INC.UTAS System Type-52L Pattern/Multifocal/SunBurst2022-06-27
00857901006606UTASL K C TECHNOLOGIES, INC.UTAS System Type-64L2022-06-27
00857901006385UTASL K C TECHNOLOGIES, INC.UTAS System Type-50 Pattern/Multifocal2022-02-04
00857901006392UTASL K C TECHNOLOGIES, INC.UTAS System Type-51 Pattern/Multifocal/RETeval2022-02-04
00857901006408UTASL K C TECHNOLOGIES, INC.UTAS System Type-52 Pattern/Multifocal/SunBurst2022-02-04
00857901006415UTASL K C TECHNOLOGIES, INC.UTAS System Type-53 Pattern/Multifocal/SunBurst/RE2022-02-04
00857901006422UTASL K C TECHNOLOGIES, INC.UTAS System Type-54 Dark Adapt 2022-02-04
00857901006460RETeval™L K C TECHNOLOGIES, INC.RETeval Complete w/o Electrodes2022-02-04
00857901006477RETeval™L K C TECHNOLOGIES, INC.RETeval Complete w/o Electrodes2022-02-04
00855730007290EspionDIAGNOSYS LLCD3102021-04-26
00855730007306EspionDIAGNOSYS LLCD3152021-04-26
00855730007313EspionDIAGNOSYS LLCD3412021-04-26
00855730007276EspionDIAGNOSYS LLCD3102021-04-13
00855730007283EspionDIAGNOSYS LLCD3102021-04-13
00855730007269EspionDIAGNOSYS LLCD3102021-04-08
00857901006378UTASL K C TECHNOLOGIES, INC.UTAS System Type-102021-03-19
00857901006361UTAS/RETevalL K C TECHNOLOGIES, INC.UTAS System Type-652021-03-11
00857901006354UTASL K C TECHNOLOGIES, INC.UTAS System Type-642021-03-08
00855730007252EspionDIAGNOSYS LLCD3102020-12-02
00855730007245EspionDIAGNOSYS LLCD3152020-07-28
00855730007238EspionDIAGNOSYS LLCD3152020-04-16
00855730007221EspionDIAGNOSYS LLCD3102020-03-18
00855730007214EspionDIAGNOSYS LLCD3102020-02-11
00855730007207EspionDIAGNOSYS LLCD3152020-01-27
00855730007191EspionDIAGNOSYS LLCD3152019-10-18
00855730007177EspionDIAGNOSYS LLCD3152019-09-19
00855730007184EspionDIAGNOSYS LLCD3152019-09-19
00850594007028EspionDIAGNOSYS LLCD3102016-08-31
00850594007035EspionDIAGNOSYS LLCD3102016-08-31
00850594007042EspionDIAGNOSYS LLCD3102016-08-31
00850594007059EspionDIAGNOSYS LLCD3102016-08-31
00850594007066EspionDIAGNOSYS LLCD3102016-08-31
00850594007073EspionDIAGNOSYS LLCD3102016-08-31
00850594007080EspionDIAGNOSYS LLCD3102016-08-31
00850594007097EspionDIAGNOSYS LLCD3102016-08-31
00850594007103EspionDIAGNOSYS LLCD3102016-08-31
00850594007110EspionDIAGNOSYS LLCD3102016-08-31
00850594007127EspionDIAGNOSYS LLCD3152016-08-31
00850594007134EspionDIAGNOSYS LLCD3152016-08-31
00850594007141EspionDIAGNOSYS LLCD3152016-08-31
00850594007158EspionDIAGNOSYS LLCD3152016-08-31
00850594007165EspionDIAGNOSYS LLCD3152016-08-31
00850594007172EspionDIAGNOSYS LLCD3152016-08-31
00850594007189EspionDIAGNOSYS LLCD3152016-08-31
00850594007196EspionDIAGNOSYS LLCD3152016-08-31
00850594007202EspionDIAGNOSYS LLCD3152016-08-31
00850594007219EspionDIAGNOSYS LLCD3152016-08-31
00850594007226EspionDIAGNOSYS LLCD3102016-09-01
00850594007233EspionDIAGNOSYS LLCD3102016-09-19
00850594007240EspionDIAGNOSYS LLCD3102016-09-19
00850594007257EspionDIAGNOSYS LLCD3102016-09-19
00850594007264EspionDIAGNOSYS LLCD3102016-09-19
00850594007271EspionDIAGNOSYS LLCD3102016-09-19
00850594007288EspionDIAGNOSYS LLCD3102016-09-19
00850594007295EspionDIAGNOSYS LLCD3102016-09-19
00850594007301EspionDIAGNOSYS LLCD3102016-09-19
00850594007318EspionDIAGNOSYS LLCD3102016-09-22
00850594007325EspionDIAGNOSYS LLCD3102016-09-23
00850594007332EspionDIAGNOSYS LLCD3102016-09-23