HKI · Class II · 21 CFR 886.1120

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

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

157
Total
157
Cleared
123d
Avg days
1977
Since
157 devices
97–120 of 157
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 Mar 08, 2004
PANORET, MODEL PNM 60
K040325
Medibell Medical Vision Technologies , Ltd.
Ophthalmic · 27d
Cleared Jun 06, 2003
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629
Canon USA, Inc.
Ophthalmic · 10d
Cleared Dec 23, 2002
MP-1 MICRO PERIMETER
K023719
Nidek Technologies Srl
Ophthalmic · 48d
Cleared Nov 07, 2002
FUNDUS AUTOIMAGER
K020888
Visual Pathways, Inc.
Ophthalmic · 234d
Cleared Jul 26, 2002
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K022164
Zeta Development Laboratories
Ophthalmic · 23d
Cleared Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274
Nidek, Inc.
Ophthalmic · 111d
Cleared Sep 26, 2001
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
K011877
Carl Zeiss Jena GmbH
Ophthalmic · 103d
Cleared Jun 01, 2001
ISCREEN VISION SCREENER
K010315
Iscreen, LLC
Ophthalmic · 119d
Cleared Dec 18, 2000
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K002920
Escalon Medical Corp.
Ophthalmic · 90d
Cleared Nov 02, 2000
RETINADX
K003236
Regulatory Associates, Inc.
Ophthalmic · 16d
Cleared Jul 13, 2000
RETCAM II
K001275
Massie Research Laboratories, Inc.
Ophthalmic · 84d
Cleared May 04, 2000
EYECAP IMAGING SYSTEM
K000368
Clement Clarke Intl., Ltd.
Ophthalmic · 90d
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