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
121–144 of 157
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 Dec 01, 1995
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
K954780
Kowa Optimed, Inc.
Ophthalmic · 45d
Cleared Dec 01, 1995
KOWA GENESIS HAND-HELD FUNDUS CAMERA
K954781
Kowa Optimed, Inc.
Ophthalmic · 45d
Cleared Nov 17, 1995
ANGIOVISION VIEWING STATION
K953972
Medivision Medical Imaging, Ltd.
Ophthalmic · 86d
Cleared Nov 17, 1995
ANGIOVISION 1000
K953973
Medivision Medical Imaging, Ltd.
Ophthalmic · 86d
Cleared Aug 25, 1995
ORIMS DIGITAL ANGIOGRAPHY SYSTEM
K952480
Midwest Ophthalmic Instruments, Inc.
Ophthalmic · 87d
Cleared Jun 07, 1995
NON-MYDRIATIC RETINAL CAMERA
K941234
Canon USA, Inc.
Ophthalmic · 449d
Cleared Mar 01, 1995
KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000
K950091
Konan Medical, Inc.
Ophthalmic · 50d
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 Aug 09, 1993
MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS
K930442
Marco Ophthalmic, Inc.
Ophthalmic · 195d
Cleared Mar 19, 1993
LEMPERT OPTIC DISC ANALYSIS SYSTEM
K923708
Lempert Ophthalmic Instruments
Ophthalmic · 235d
Cleared Mar 04, 1993
CHROMOS IMAGER
K923958
Chromos Imaging, Inc.
Ophthalmic · 210d
Cleared Jan 23, 1992
CANDELA RETINAL CAMERA
K913314
Candela Laser Corp.
Ophthalmic · 182d
Cleared Nov 27, 1991
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
K913929
Ophthalmic Imaging Systems
Ophthalmic · 85d
Cleared Jun 17, 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439
Canon USA, Inc.
Ophthalmic · 76d
Cleared Oct 04, 1989
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474
Canon USA, Inc.
Ophthalmic · 23d
Cleared Feb 28, 1989
NEVISCAN MODEL N - 100
K884989
Special Products, Inc.
Hematology · 89d
Cleared Jan 26, 1988
OPACITY LENSMETER 701
K874355
Intraoptics, Inc.
Ophthalmic · 95d
Cleared Nov 02, 1987
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017
Canon USA, Inc.
Ophthalmic · 31d