FDA.reportPublic FDA data

Ophthalmic fundus camera

Definition
An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.
GUDID devices
236
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628678036017WRI-1Cellview Imaging Inc.012022-09-08
00857253006019ICON HandpiecePhoenix ClinicalPCI 40-10022026-04-03
00857253006033FA ModulePhoenix ClinicalPCI 40-10042026-04-03
00857253006071DiffuserPhoenix ClinicalPCI 40-10172026-04-03
00857253006101Phoenix ICON with Training KitPhoenix ClinicalPCI 40-11002026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalPCI 40-1100FA2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalPCI 40-21002026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalPCI 40-2100FA2026-04-03
00864222000404RetCam 3NATUS MEDICAL INCRetCam 32017-12-04
00864222000411RetCam ShuttleNATUS MEDICAL INCRetCam Shuttle2017-12-04
00864222000428RetCam PortableNATUS MEDICAL INCRetCam Portable2017-12-04
04571130283152NON-MYDRIATIC RETINAL CAMERA NW500TOPCON CORPORATIONNW5002022-09-15
06430046260634Visuscout 100 set FNOptomed Oy60100054A2019-11-26
06945087516225MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.FC1622021-05-18
08053677040017DRSCENTERVUE SPADRS2016-07-29
08053677040123EIDONCENTERVUE SPAEIDON UWF Module2026-04-29
08056098470319S4 OPTIKCOSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRLCOBRA2016-09-13
08719326032108EasyScanEasyScan B.V.EasyScan2016-09-17
089080077540063nethraFORUS HEALTH PRIVATE LIMITEDClassic camera2016-09-14
089080077540133nethraFORUS HEALTH PRIVATE LIMITEDStand2016-09-14
089080077540203nethraFORUS HEALTH PRIVATE LIMITEDneo probe2017-08-31
089080077540373nethraFORUS HEALTH PRIVATE LIMITEDneo control box2017-08-31
089080077540443nethraFORUS HEALTH PRIVATE LIMITEDneo P1000 probe2018-04-06
089080077540513nethraFORUS HEALTH PRIVATE LIMITEDneo P1000 control box2018-04-06
10857253006085Phoenix ICON GO Control BoxPhoenix ClinicalPCI 40-10302026-05-14
B667NEXY1NEXYNEXT SIGHT SRL012018-06-18
B667PROTOZ1PROTOZNEXT SIGHT SRL012019-12-09
00860014277559MarcoLombart Brothers, Inc.Marco iON2026-03-02
05713315011597RetCam EnvisionNatus Medical Denmark ApS61-0003002026-02-10
05713315011641RetCam EnvisionNatus Medical Denmark ApSRETCAM-FA-UPGRADE2026-02-10
05713315011924RetCam EnvisionNatus Medical Denmark ApS60-0000702026-02-10
05713315011931RetCam EnvisionNatus Medical Denmark ApS60-0000902026-02-10
05713315011948RetCam EnvisionNatus Medical Denmark ApS60-0000922026-02-10
05713315011962RetCam EnvisionNatus Medical Denmark ApS61-0005002026-02-10
06430046260993Optomed Lumo Camera setOptomed Oy60102406A2025-11-13
06973211070619Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD SK-650B2025-08-18
06973211071500Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDSK-680B2025-08-18
06973211071517Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDSK-680C2025-08-18
00850067214229identifeye Camera System, tabletIdentifeye Health Inc.815-30023-012025-07-07
00850067214236identifeye Camera System, power supplyIdentifeye Health Inc.815-30020-002025-07-07
00850067214274identifeye Camera SystemIdentifeye Health Inc.850-30003-002025-07-07
00850067214281identifeye Camera System, reconditionedIdentifeye Health Inc.850-30004-002025-07-07
00860014304507OptainOptain Health, Inc.Resolve Fundus Camera2025-07-07
00860000249584Verily Numetric Retinal Camera VERILY LIFE SCIENCES LLCVNRC -1012025-02-24
00852788008019NeolightNEOLIGHT LLCPCI 40-10032025-01-26
00852788008026NeolightNEOLIGHT LLCPCI 40-10042025-01-26
00852788008040NeolightNEOLIGHT LLCPCI 40-10172025-01-26
00852788008057NeolightNEOLIGHT LLCPCI 40-10302025-01-26
00852788008064NeolightNEOLIGHT LLCPCI 30-10002025-01-26
00852788008071NeolightNEOLIGHT LLCPCI 40-10052025-01-26
10852788008085NeolightNEOLIGHT LLCPCI 40-10022025-01-26
20852788008020NeolightNEOLIGHT LLCPCI 40-1100FA2025-01-26
20852788008037NeolightNEOLIGHT LLCPCI 40-1100 2025-01-26
20852788008044NeolightNEOLIGHT LLCPCI 40-21002025-01-26
20852788008051NeolightNEOLIGHT LLCPCI 40-2100FA2025-01-26
03664188000435ESSILORLUNEAU TECHNOLOGY OPERATIONSRetina 8002025-01-02
089080077540683nethraFORUS HEALTH PRIVATE LIMITEDneo probe2019-01-21
089080077540753nethraFORUS HEALTH PRIVATE LIMITEDneo control box2019-01-21
08800016904055ReticaptureCLASSYS Inc.DNC-C12024-10-30
00382830062466NatusXLTEK60-0000702024-09-30
06976107790301AirdocChangsha Airdoc Health Technology Co., Ltd.AI-FD16aN2024-09-27
07908616100097Eyer 2 BasicPHELCOM TECHNOLOGIES SAEyer 2 Basic2024-09-23
04549292228489CANON INC.CANON INC.CR-102024-07-29
00860011978305EntireEye PortableRETIVUE, LLCWFP-B-G1.5-0A2024-07-18
04719876420398Vitazi View™CRYSTALVUE MEDICAL CORPORATIONVitaziView2024-05-20
03664188000411VisionixLUNEAU TECHNOLOGY OPERATIONSVX6102024-04-30
00811608014708Volk VivaVOLK OPTICAL INC.VVIVA1A2024-04-05
00811608014739Volk VivaVOLK OPTICAL INC.VVIVA1B2024-04-05
00627987702132Optina-4COptina Diagnostiques, IncMHRC-C1N2024-02-08
00860010826812Oivi Opthalmic Fundus CameraOivi ASOFC100L2024-01-15
00853501008002Spect Ophthalmic CameraSpect Inc.BOM0012023-08-10
03615020000267ESSILOR RETINA 400ESSILOR INTERNATIONALRETINA 4002016-09-23
04987669101544MICROPERIMETERNIDEK CO.,LTD.MP-3 type S2023-06-12
03664188000381VisionixLUNEAU TECHNOLOGY OPERATIONSNexy2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSDNEye Scanner 32023-06-08
03664188000428Carl Zeiss MeditecLUNEAU TECHNOLOGY OPERATIONSVelara 2002023-06-08
10860000249543Verily Retinal CameraVERILY LIFE SCIENCES LLCVRC-1002023-05-24
07908616100011EyerPHELCOM TECHNOLOGIES SAEyer NM-STD2023-04-27
07908616100042EyerPHELCOM TECHNOLOGIES SAEyer M-STD2023-04-27
04049539072023RESIGHT 500Carl Zeiss Meditec AG302721-9020-0002023-03-31