HKI · Class II · 21 CFR 886.1120

FDA Product Code HKI: Camera, Ophthalmic, Ac-powered

Leading manufacturers include Canon USA, Inc., Canon, Inc. and Nidek, Inc..

157
Total
157
Cleared
123d
Avg days
1977
Since
157 devices
25–48 of 157
Cleared Jun 04, 2019
KOWA DR-1a
K190573
Kowa Company , Ltd.
Ophthalmic · 90d
Cleared Apr 01, 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
K190198
Nidek Co., Ltd.
Ophthalmic · 56d
Cleared Jan 02, 2019
NFC-700 non-mydriatic auto fundus camera
K182199
Crystalvue Medical Corporation
Ophthalmic · 141d
Cleared Dec 21, 2018
3nethra neo
K183059
Forus Health Pvt.Ltd
Ophthalmic · 49d
Cleared Dec 10, 2018
LipiScan Dynamic Meibomian Imager
K182506
Tearscience, Inc.
Ophthalmic · 89d
Cleared Sep 07, 2018
RetCam 3
K182263
Natus Medical Incorporated
Ophthalmic · 17d
Cleared Jul 27, 2018
RetiCapture
K173474
Ilooda Co,., Ltd.
Ophthalmic · 260d
Cleared Jun 08, 2018
Nexy
K180306
Next Sight Srl
Ophthalmic · 126d
Cleared Apr 05, 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K180378
Optomed OY
Ophthalmic · 52d
Cleared Dec 20, 2012
PANOPTIC
K121405
Welch Allyn, Inc.
Ophthalmic · 224d
Cleared Sep 14, 2011
DIGITAL RETINAL CAMERA
K111612
Canon, Inc.
Ophthalmic · 97d
Cleared Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466
Canon, Inc.
Ophthalmic · 30d
Cleared Apr 24, 2008
CR-1
K080883
Canon, Inc.
Ophthalmic · 24d
Cleared Jan 23, 2007
CF-1
K063717
Canon, Inc.
Ophthalmic · 40d
Cleared Nov 02, 2005
VISUCAM PRO NM
K052268
Carl Zeiss Meditec, AG
Ophthalmic · 75d
Cleared Feb 14, 2005
VISCUCAM C DIGITAL CAMERA
K043222
Carl Zeiss Meditec, AG
Ophthalmic · 84d
Cleared Jun 23, 2004
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K041546
Canon, Inc.
Ophthalmic · 14d
Cleared Jun 06, 2003
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629
Canon USA, Inc.
Ophthalmic · 10d
Cleared Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274
Nidek, Inc.
Ophthalmic · 111d
Cleared May 06, 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246
Canon USA, Inc.
Ophthalmic · 103d
Cleared Nov 04, 1997
NIDEK HANDY
K973218
Nidek, Inc.
Ophthalmic · 69d
Cleared Nov 04, 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K973533
Nidek, Inc.
Ophthalmic · 47d
Cleared Jun 07, 1995
NON-MYDRIATIC RETINAL CAMERA
K941234
Canon USA, Inc.
Ophthalmic · 449d
Cleared Feb 03, 1995
60 FUNDUS CAMERA CF-60UV
K946058
Canon USA, Inc.
Ophthalmic · 87d