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 Oct 01, 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
K092056
Optomed OY
Ophthalmic · 86d
Cleared Aug 07, 2009
KOWAGENESIS-DF
K091098
Kowa Co. , Ltd.
Ophthalmic · 113d
Cleared Jul 02, 2009
KOWA VX-10 A
K091683
Kowa Co. , Ltd.
Ophthalmic · 22d
Cleared Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
K090115
Topcon Corp.
Ophthalmic · 160d
Cleared Jun 16, 2009
STATIC VESSEL ANALYZER
K082196
Imedos GmbH
Ophthalmic · 316d
Cleared Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466
Canon, Inc.
Ophthalmic · 30d
Cleared Jan 30, 2009
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
K083771
Clarity Medical Systems
Ophthalmic · 43d
Cleared Jan 16, 2009
MODIFICATION TO KOWA NONMYD ALPHA-DIII
K083387
Kowa Co. , Ltd.
Ophthalmic · 60d
Cleared Nov 05, 2008
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K081858
Clarity Medical Systems
Ophthalmic · 127d
Cleared Oct 21, 2008
KOWA NONMYD ALPHA-DIII
K082767
Kowa Co. , Ltd.
Ophthalmic · 29d
Cleared Jun 11, 2008
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
K080180
Optical Imaging , Ltd.
Ophthalmic · 139d
Cleared Apr 24, 2008
CR-1
K080883
Canon, Inc.
Ophthalmic · 24d
Cleared Apr 04, 2008
KOWA GENESIS-D
K080681
Kowa Co. , Ltd.
Ophthalmic · 25d
Cleared Apr 24, 2007
ORION
K070231
Nidek Technologies Srl
Ophthalmic · 90d
Cleared Jan 23, 2007
CF-1
K063717
Canon, Inc.
Ophthalmic · 40d
Cleared Nov 17, 2006
RETINAL FUNCTIONAL IMAGER (RFI)
K062416
Optical Imaging , Ltd.
Ophthalmic · 92d
Cleared Nov 01, 2006
KOWA VX-10I
K062021
Kowa Co. , Ltd.
Ophthalmic · 107d
Cleared Oct 20, 2006
IRI INTEGRATED RETINAL IMAGER
K062295
Medivision Medical Imaging, Ltd.
Ophthalmic · 74d
Cleared Sep 28, 2006
MP-1 MICROPERIMETER
K061768
Nidek Technologies Srl
Ophthalmic · 97d
Cleared Sep 27, 2006
KOWA NONMYD ALPHA-D
K062356
Kowa Co. , Ltd.
Ophthalmic · 44d
Cleared Jan 24, 2006
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
K053044
Opto Global, Inc.
Ophthalmic · 88d
Cleared Nov 10, 2005
KOWA NONMYD 7, KOWA NONMYD A-D
K053026
Kowa Co. , Ltd.
Ophthalmic · 14d
Cleared Nov 03, 2005
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
K050271
Kowa Co. , Ltd.
Ophthalmic · 272d
Cleared Nov 02, 2005
VISUCAM PRO NM
K052268
Carl Zeiss Meditec, AG
Ophthalmic · 75d