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
49–72 of 157
Cleared Mar 19, 2013
DIGITAL RETINAL CAMERA
K123208
Canon Inc. -Medical Equipment Group
Ophthalmic · 158d
Cleared Feb 06, 2013
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
K123460
Topcon Medical Systems, Inc.
Ophthalmic · 89d
Cleared Jan 11, 2013
ICAM FUNDUS CAMERA
K122572
Optovue, Inc.
Ophthalmic · 141d
Cleared Dec 31, 2012
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K122481
Tearscience, Inc.
Ophthalmic · 139d
Cleared Dec 20, 2012
PANOPTIC
K121405
Welch Allyn, Inc.
Ophthalmic · 224d
Cleared Sep 28, 2012
DIGITAL EYE-FUNDUS CAMERA
K120982
Medimaging Integrated Solutions, Inc. (Miis)
Ophthalmic · 179d
Cleared May 08, 2012
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
K113451
Nidek Technologies Srl
Ophthalmic · 169d
Cleared Feb 16, 2012
KOWA VX-20
K112330
Kowa Co. , Ltd.
Ophthalmic · 188d
Cleared Nov 30, 2011
NON-CONTACT TEAR FILM THERMOGRAGH
K111771
United Integrated Services Co., Ltd.
Ophthalmic · 160d
Cleared Sep 14, 2011
DIGITAL RETINAL CAMERA
K111612
Canon, Inc.
Ophthalmic · 97d
Cleared May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K110986
Optomed OY
Ophthalmic · 38d
Cleared Jan 26, 2011
KOWA NONMYD WX
K101628
Kowa Co. , Ltd.
Ophthalmic · 230d
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 Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466
Canon, Inc.
Ophthalmic · 30d
Cleared Jan 16, 2009
MODIFICATION TO KOWA NONMYD ALPHA-DIII
K083387
Kowa Co. , Ltd.
Ophthalmic · 60d
Cleared Oct 21, 2008
KOWA NONMYD ALPHA-DIII
K082767
Kowa Co. , Ltd.
Ophthalmic · 29d
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 Jan 23, 2007
CF-1
K063717
Canon, Inc.
Ophthalmic · 40d
Cleared Nov 01, 2006
KOWA VX-10I
K062021
Kowa Co. , Ltd.
Ophthalmic · 107d
Cleared Sep 27, 2006
KOWA NONMYD ALPHA-D
K062356
Kowa Co. , Ltd.
Ophthalmic · 44d
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