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Camera, Ophthalmic, Ac-Powered

FDA product code HKI · 153 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.1120
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-03 – 2026-06-22

HKI 2002-07-26

ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM

Applicant Zeta Development Laboratories

K number K022164

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HKI 2002-04-17

NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000

Applicant Nidek, Inc.

K number K014274

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HKI 2001-09-26

FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM

Applicant Carl Zeiss Jena GmbH

K number K011877

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HKI 2001-06-01

ISCREEN VISION SCREENER

Applicant Iscreen, LLC

K number K010315

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HKI 2000-12-18

MEGAVISION CPX, MEGAVISION FA, MODEL I AND II

Applicant Escalon Medical Corp.

K number K002920

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HKI 2000-11-02

RETINADX

Applicant Regulatory Associates, Inc.

K number K003236

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HKI 2000-07-13

RETCAM II

Applicant Massie Research Laboratories, Inc.

K number K001275

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HKI 2000-05-04

EYECAP IMAGING SYSTEM

Applicant Clement Clarke Intl., Ltd.

K number K000368

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HKI 1999-03-26

DIGISCOPE OPHTHALMIC CAMERA

Applicant Eye Tel Imaging, Inc.

K number K990205

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HKI 1998-10-23

WINSTATION RETINAL IMAGER

Applicant Ophthalmic Imaging Systems

K number K982689

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HKI 1998-08-14

DISCAM DIGITAL IMAGING SYSTEM

Applicant Marcher Enterprises, Ltd.

K number K974535

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HKI 1998-05-19

OPHTHAVISION IMAGING SYSTEM

Applicant Mrp Group, Inc.

K number K980295

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HKI 1998-05-06

NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM

Applicant Canon USA, Inc.

K number K980246

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HKI 1998-04-24

KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER

Applicant Konan, Inc.

K number K980357

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HKI 1997-12-12

RETINAL CUBE

Applicant Applied Spectral Imaging , Ltd.

K number K973950

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HKI 1997-11-04

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

Applicant Nidek, Inc.

K number K973533

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HKI 1997-11-04

NIDEK HANDY

Applicant Nidek, Inc.

K number K973218

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HKI 1997-09-30

CATARACTSCREENER CT - S

Applicant Neitz Instruments Company, Ltd.

K number K972440

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HKI 1997-06-24

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM

Applicant Tomey Corporation USA

K number K971685

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HKI 1996-10-22

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)

Applicant Karl Storz Imaging, Inc.

K number K963333

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HKI 1996-01-03

KOWA SC-1200 PHOTO SLIT LAMP SYSTEM

Applicant Kowa Optimed, Inc.

K number K955442

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HKI 1995-12-01

KOWA GENESIS HAND-HELD FUNDUS CAMERA

Applicant Kowa Optimed, Inc.

K number K954781

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HKI 1995-12-01

KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C

Applicant Kowa Optimed, Inc.

K number K954780

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HKI 1995-11-17

ANGIOVISION 1000

Applicant Medivision Medical Imaging, Ltd.

K number K953973

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HKI 1995-11-17

ANGIOVISION VIEWING STATION

Applicant Medivision Medical Imaging, Ltd.

K number K953972

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HKI 1995-08-25

ORIMS DIGITAL ANGIOGRAPHY SYSTEM

Applicant Midwest Ophthalmic Instruments, Inc.

K number K952480

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HKI 1995-06-07

NON-MYDRIATIC RETINAL CAMERA

Applicant Canon USA, Inc.

K number K941234

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HKI 1995-03-01

KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000

Applicant Konan Medical, Inc.

K number K950091

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HKI 1995-02-03

60 FUNDUS CAMERA CF-60UV

Applicant Canon USA, Inc.

K number K946058

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HKI 1994-02-22

60 DEGREE FUNDUS CAMERA, CF-60UD

Applicant Canon USA, Inc.

K number K934663

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HKI 1993-08-09

MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS

Applicant Marco Ophthalmic, Inc.

K number K930442

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HKI 1993-03-19

LEMPERT OPTIC DISC ANALYSIS SYSTEM

Applicant Lempert Ophthalmic Instruments

K number K923708

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HKI 1993-03-04

CHROMOS IMAGER

Applicant Chromos Imaging, Inc.

K number K923958

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HKI 1992-01-23

CANDELA RETINAL CAMERA

Applicant Candela Laser Corp.

K number K913314

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HKI 1991-11-27

DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

Applicant Ophthalmic Imaging Systems

K number K913929

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HKI 1991-06-17

NON-MYDRIATIC RETINAL CAMERA, CR-45UAF

Applicant Canon USA, Inc.

K number K911439

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HKI 1989-10-04

NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL

Applicant Canon USA, Inc.

K number K895474

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HKI 1989-02-28

NEVISCAN MODEL N - 100

Applicant Special Products, Inc.

K number K884989

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HKI 1988-01-26

OPACITY LENSMETER 701

Applicant Intraoptics, Inc.

K number K874355

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HKI 1987-11-02

MODIFIED RETINAL CAMERA MODEL CR4-45NM

Applicant Canon USA, Inc.

K number K874017

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HKI 1987-09-30

OXFORD RETRO-ILLUMINATION CATARACT CAMERA

Applicant Holofax , Ltd.

K number K873157

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HKI 1986-08-21

CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM

Applicant Canon USA, Inc.

K number K862323

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HKI 1986-02-27

CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM

Applicant Canon USA, Inc.

K number K855170

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HKI 1985-12-13

IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM

Applicant Par Technology Park

K number K854330

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HKI 1985-08-12

HUMPHREY IMAGE ANALYZER MODEL 110

Applicant Zeiss Humphrey System

K number K852638

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HKI 1985-01-28

GRC-WT, GRC-W

Applicant Olympus Corp.

K number K843899

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HKI 1985-01-22

CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM

Applicant Canon USA, Inc.

K number K844898

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HKI 1984-10-05

CANON 60 FUNDUS CAMERA CF-60U

Applicant Canon USA, Inc.

K number K843021

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HKI 1984-03-02

TEXAS BIO SCAN

Applicant Texas Bio Scan

K number K833694

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HKI 1983-02-24

AO DOCUSTAR(MMIRO) FUNDUS CAMERA

Applicant Warner-Lambert Co.

K number K822991

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HKI 1983-01-05

AML (ANGLE MAGNIFYING LENS

Applicant Nikon, Inc.

K number K823719

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HKI 1983-01-05

COHERENT FUNDUSL RETINAL CAMERA

Applicant Coherent Medical Division

K number K822908

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HKI 1977-06-03

POMERANTZEFF EQUATOR PLUS CAMERA

Applicant Medical Instrument Research Assoc., Inc.

K number K770888

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