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 Jun 23, 2011
VISTA DIGITAL OPTHALMOSCOPE
K102412
Eyequick.Llc
Ophthalmic · 303d
Cleared May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K110986
Optomed OY
Ophthalmic · 38d
Cleared Apr 20, 2011
RETCAM 3 OPTHALMIC IMAGING SYSTEM
K102859
Clarity Medical Systems
Ophthalmic · 202d
Cleared Jan 26, 2011
KOWA NONMYD WX
K101628
Kowa Co. , Ltd.
Ophthalmic · 230d
Cleared Jan 12, 2011
ISCREEN VISION SCREENER
K102651
Iscreen Vision, Inc.
Ophthalmic · 120d
Cleared Dec 22, 2010
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
K101861
Truevision Systems, Incorporated
Ophthalmic · 173d
Cleared Nov 17, 2010
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
K093071
Fundus Photo, LLC
Ophthalmic · 413d
Cleared Oct 29, 2010
DIGITAL RETINAL CAMERA
K102013
Canon Inc. -Medical Equipment Group
Ophthalmic · 105d
Cleared Oct 27, 2010
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K101935
Centervue S.P.A.
Ophthalmic · 107d
Cleared Mar 18, 2010
DIGITAL RETINAL CAMERA CX-1
K092565
Canon Components, Inc.
Ophthalmic · 210d
Cleared Feb 12, 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207
Topcon Corp.
Ophthalmic · 18d
Cleared Nov 25, 2009
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
K090326
Clarity Medical Systems
Ophthalmic · 289d
Cleared Nov 17, 2009
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K092374
Ophthalmic Imaging Systems
Ophthalmic · 104d
Cleared Oct 23, 2009
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K091935
Tearscience, Inc.
Ophthalmic · 115d