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
145–157 of 157
Cleared Sep 30, 1987
OXFORD RETRO-ILLUMINATION CATARACT CAMERA
K873157
Holofax , Ltd.
Ophthalmic · 51d
Cleared Aug 21, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323
Canon USA, Inc.
Ophthalmic · 63d
Cleared Feb 27, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170
Canon USA, Inc.
Ophthalmic · 63d
Cleared Dec 13, 1985
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM
K854330
Par Technology Park
Ophthalmic · 46d
Cleared Aug 12, 1985
HUMPHREY IMAGE ANALYZER MODEL 110
K852638
Zeiss Humphrey System
Ophthalmic · 53d
Cleared Jan 28, 1985
GRC-WT, GRC-W
K843899
Olympus Corp.
Ophthalmic · 117d
Cleared Jan 22, 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898
Canon USA, Inc.
Ophthalmic · 36d
Cleared Oct 05, 1984
CANON 60 FUNDUS CAMERA CF-60U
K843021
Canon USA, Inc.
Ophthalmic · 65d
Cleared Mar 02, 1984
TEXAS BIO SCAN
K833694
Texas Bio Scan
Ophthalmic · 136d
Cleared Feb 24, 1983
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
K822991
Warner-Lambert Co.
Ophthalmic · 135d
Cleared Jan 05, 1983
COHERENT FUNDUSL RETINAL CAMERA
K822908
Coherent Medical Division
Ophthalmic · 97d
Cleared Jan 05, 1983
AML (ANGLE MAGNIFYING LENS
K823719
Nikon, Inc.
Ophthalmic · 26d
Cleared Jun 03, 1977
POMERANTZEFF EQUATOR PLUS CAMERA
K770888
Medical Instrument Research Assoc., Inc.
Ophthalmic · 18d