HKI · Class II · 21 CFR 886.1120

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

Leading manufacturers include Canon USA, Inc., Kowa Co. , Ltd. and Canon, Inc..

157
Total
157
Cleared
123d
Avg days
1977
Since
157 devices
73–96 of 157
Cleared Nov 02, 2005
VISUCAM PRO NM
K052268
Carl Zeiss Meditec, AG
Ophthalmic · 75d
Cleared Oct 06, 2005
KOWA VX-10
K043213
Kowa Co. , Ltd.
Ophthalmic · 321d
Cleared Feb 14, 2005
VISCUCAM C DIGITAL CAMERA
K043222
Carl Zeiss Meditec, AG
Ophthalmic · 84d
Cleared Nov 05, 2004
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
K041367
Topcon Corp.
Ophthalmic · 165d
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 Mar 26, 1999
DIGISCOPE OPHTHALMIC CAMERA
K990205
Eye Tel Imaging, Inc.
Ophthalmic · 64d
Cleared Oct 23, 1998
WINSTATION RETINAL IMAGER
K982689
Ophthalmic Imaging Systems
Ophthalmic · 81d
Cleared Aug 14, 1998
DISCAM DIGITAL IMAGING SYSTEM
K974535
Marcher Enterprises, Ltd.
Ophthalmic · 255d
Cleared May 19, 1998
OPHTHAVISION IMAGING SYSTEM
K980295
Mrp Group, Inc.
Ophthalmic · 112d
Cleared May 06, 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246
Canon USA, Inc.
Ophthalmic · 103d
Cleared Apr 24, 1998
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
K980357
Konan, Inc.
Ophthalmic · 85d
Cleared Dec 12, 1997
RETINAL CUBE
K973950
Applied Spectral Imaging , Ltd.
Ophthalmic · 57d
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 Sep 30, 1997
CATARACTSCREENER CT - S
K972440
Neitz Instruments Company, Ltd.
Ophthalmic · 92d
Cleared Jun 24, 1997
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
K971685
Tomey Corporation USA
Ophthalmic · 48d
Cleared Oct 22, 1996
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
K963333
Karl Storz Imaging, Inc.
Ophthalmic · 60d
Cleared Jan 03, 1996
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
K955442
Kowa Optimed, Inc.
Ophthalmic · 36d
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
Cleared Feb 22, 1994
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663
Canon USA, Inc.
Ophthalmic · 147d
Cleared Jan 23, 1992
CANDELA RETINAL CAMERA
K913314
Candela Laser Corp.
Ophthalmic · 182d