Product Code: HKI FDA class 2 21 CFR 886.1120

Camera, Ophthalmic, Ac-Powered

Ophthalmic

The AC-Powered Ophthalmic Camera is an imaging device used to capture photographs or video of ocular structures, including the fundus, anterior segment, or external eye, for documentation, diagnosis, and monitoring of eye conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing in the United States. The product code is HKI, regulated under 21 CFR 886.1120, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

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510(k)s

156

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HKI
Device Class: FDA class 2
Regulation Number: 886.1120
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 156 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251353	Eyer 2	Jan 16, 2026	Substantially Equivalent	Phelcom Technologies
K252120	Fundus On Phone Non Mydriatic (FOP NM-10)	Dec 12, 2025	Substantially Equivalent	Remidio Innovative Solutions Private Limited
K250770	Optina-4C (MHRC-C1N)	Sep 04, 2025	Substantially Equivalent	Optina Diagnostics, Inc.
K243600	3nethra neo HD FA; 3nethra neo HD	Aug 14, 2025	Substantially Equivalent	Forus Health Pvt.Ltd
K250683	Resolve Fundus Camera	Apr 30, 2025	Substantially Equivalent	Optain Health, Inc.
K243664	Sentinel Camera	Dec 17, 2024	Substantially Equivalent	Ai Optics
K242508	Verily Numetric Retinal Camera	Dec 09, 2024	Substantially Equivalent	Verily Life Sciences, LLC
K241049	CANON Fundus Camera CR-10 (CR-10)	May 15, 2024	Substantially Equivalent	Canon, Inc.
K231230	Optina-4C (MHRC-C1N)	Dec 05, 2023	Substantially Equivalent	Optina Diagnostics, Inc.
K230627	Zilia Ocular FC (ZIL-10002)	Nov 20, 2023	Substantially Equivalent	Zilia, Inc.
K223575	Phoenix ICON, Phoenix ICON GO	Sep 06, 2023	Substantially Equivalent	Neolight, LLC
K223381	iExaminer System with Panoptic Plus	Mar 15, 2023	Substantially Equivalent	Welch Allyn, Inc.
K221329	Eyer Retinal Camera NM-STD	Feb 22, 2023	Substantially Equivalent	Phelcom Technologies
K221111	Non-Mydriatic Retinal Camera NW500	Aug 29, 2022	Substantially Equivalent	Topcon Corporation
K210197	NFC-600 Automated Portable Retinal Camera	Apr 13, 2021	Substantially Equivalent	Crystalvue Medical Corporation
K203500	RetCam Envision	Apr 13, 2021	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K202097	Fundus Camera	Feb 02, 2021	Substantially Equivalent	Huvitz Co., Ltd.
K202221	VX650	Jan 29, 2021	Substantially Equivalent	Luneau Technology Operations
K201325	Optomed Smartscope M5 with Optomed Smartscope FA	Nov 20, 2020	Substantially Equivalent	Optomed Oyj
K201122	Canon non-mydriatic retinal camera CR series	Jul 23, 2020	Substantially Equivalent	Canon, Inc.
K193319	XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System	Jun 01, 2020	Substantially Equivalent	Vasoptic Medical, Inc.
K200254	Mydriatic Hyperspectral Retinal Camera (MHRC-C1)	Apr 27, 2020	Substantially Equivalent	Optina Diagnostics
K190954	Fundus Camera	Jan 22, 2020	Substantially Equivalent	Chongqing Bio Newvision Medical Equipment , Ltd.
K191945	KOWA nonmyd 8	Sep 10, 2019	Substantially Equivalent	Kowa Company , Ltd.
K190573	KOWA DR-1a	Jun 04, 2019	Substantially Equivalent	Kowa Company , Ltd.
K190198	Microperimeter MP-3, Microperimeter MP-3 Type S	Apr 01, 2019	Substantially Equivalent	Nidek Co., Ltd.
K182199	NFC-700 non-mydriatic auto fundus camera	Jan 02, 2019	Substantially Equivalent	Crystalvue Medical Corporation
K183059	3nethra neo	Dec 21, 2018	Substantially Equivalent	Forus Health Pvt.Ltd
K182506	LipiScan Dynamic Meibomian Imager	Dec 10, 2018	Substantially Equivalent	Tearscience, Inc.
K182263	RetCam 3 ; RetCam Shuttle ; RetCam Portable	Sep 07, 2018	Substantially Equivalent	Natus Medical Incorporated
K173474	RetiCapture	Jul 27, 2018	Substantially Equivalent	Ilooda Co,., Ltd.
K180306	Nexy	Jun 08, 2018	Substantially Equivalent	Next Sight Srl
K180378	Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module	Apr 05, 2018	Substantially Equivalent	Optomed OY
K170527	Phoenix Clinical ICON	Sep 15, 2017	Substantially Equivalent	Phoenix Technology Group, Inc. Dba Phoenix Clinical
K163021	HAAG-STREIT FUNDUS MODULE 300	Apr 11, 2017	Substantially Equivalent	Optomed OY
K161727	Eyenez Ophthalmic Camera	Oct 04, 2016	Substantially Equivalent	Eyenez, LLC
K152729	MICROPERIMETER MP-3	Jun 06, 2016	Substantially Equivalent	Nidek Co., Ltd.
K153239	LSFG-NAVI	May 12, 2016	Substantially Equivalent	Softcare Co., Ltd.
K152869	LipiView II Ocular Surface Interferometer	Jan 14, 2016	Substantially Equivalent	Tearscience, Inc.
K141325	TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA	Oct 23, 2014	Substantially Equivalent	Topcon Corp.
K141481	TRC-NW400 NON-MYDRIATIC RETINAL CAMERA	Sep 17, 2014	Substantially Equivalent	Topcon Corporation
K132987	COBRA FUNDUS CAMERA	Jul 03, 2014	Substantially Equivalent	C.S.O. S.R.L.
K140450	KEELER KAPTURE SOFTWARE	Jun 17, 2014	Substantially Equivalent	Keeler Limited
K132186	OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2	Dec 18, 2013	Substantially Equivalent	Optomed OY
K130656	IFUSION	Jul 03, 2013	Substantially Equivalent	Optovue, Inc.
K123101	TRC-50DX RETINAL CAMERA	Jun 05, 2013	Substantially Equivalent	Topcon Medical Systems, Inc.
K130289	TRC-NW8 NON-MYDRIATIC RETINAL CAMERA	May 10, 2013	Substantially Equivalent	Topcon Corp.
K123208	DIGITAL RETINAL CAMERA	Mar 19, 2013	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K123460	TRC-NW300 NON-MYDRIATIC RETINAL CAMERA	Feb 06, 2013	Substantially Equivalent	Topcon Medical Systems, Inc.
K122572	ICAM FUNDUS CAMERA	Jan 11, 2013	Substantially Equivalent	Optovue, Inc.
K122481	LIPIVIEW OCULAR SURFACE INTERFEROMETER	Dec 31, 2012	Substantially Equivalent	Tearscience, Inc.
K121405	PANOPTIC	Dec 20, 2012	Substantially Equivalent	Welch Allyn, Inc.
K120982	DIGITAL EYE-FUNDUS CAMERA	Sep 28, 2012	Substantially Equivalent	Medimaging Integrated Solutions, Inc. (Miis)
K113451	NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX	May 08, 2012	Substantially Equivalent	Nidek Technologies Srl
K112330	KOWA VX-20	Feb 16, 2012	Substantially Equivalent	Kowa Co. , Ltd.
K111771	NON-CONTACT TEAR FILM THERMOGRAGH	Nov 30, 2011	Substantially Equivalent	United Integrated Services Co., Ltd.
K111612	DIGITAL RETINAL CAMERA	Sep 14, 2011	Substantially Equivalent	Canon, Inc.
K102412	VISTA DIGITAL OPTHALMOSCOPE	Jun 23, 2011	Substantially Equivalent	Eyequick.Llc
K110986	OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1	May 16, 2011	Substantially Equivalent	Optomed OY
K102859	RETCAM 3 OPTHALMIC IMAGING SYSTEM	Apr 20, 2011	Substantially Equivalent	Clarity Medical Systems
K101628	KOWA NONMYD WX	Jan 26, 2011	Substantially Equivalent	Kowa Co. , Ltd.
K102651	ISCREEN VISION SCREENER	Jan 12, 2011	Substantially Equivalent	Iscreen Vision, Inc.
K101861	TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM	Dec 22, 2010	Substantially Equivalent	Truevision Systems, Incorporated
K093071	FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440	Nov 17, 2010	Substantially Equivalent	Fundus Photo, LLC
K102013	DIGITAL RETINAL CAMERA	Oct 29, 2010	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K101935	CENTERVUE DIGITAL RETINOGRAPHY SYSTEM	Oct 27, 2010	Substantially Equivalent	Centervue S.P.A.
K092565	DIGITAL RETINAL CAMERA CX-1	Mar 18, 2010	Substantially Equivalent	Canon Components, Inc.
K100207	NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F	Feb 12, 2010	Substantially Equivalent	Topcon Corp.
K090326	RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS	Nov 25, 2009	Substantially Equivalent	Clarity Medical Systems
K092374	OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN	Nov 17, 2009	Substantially Equivalent	Ophthalmic Imaging Systems
K091935	LIPIVIEW OCULAR SURFACE INTERFEROMETER	Oct 23, 2009	Substantially Equivalent	Tearscience, Inc.
K092056	OPTOMED SMARTSCOPE, MODEL M3-1 EY1	Oct 01, 2009	Substantially Equivalent	Optomed OY
K091098	KOWAGENESIS-DF	Aug 07, 2009	Substantially Equivalent	Kowa Co. , Ltd.
K091683	KOWA VX-10 A	Jul 02, 2009	Substantially Equivalent	Kowa Co. , Ltd.
K090115	RETINA CAMERA TRC-NW7SF MARK II	Jun 30, 2009	Substantially Equivalent	Topcon Corp.
K082196	STATIC VESSEL ANALYZER	Jun 16, 2009	Substantially Equivalent	Imedos GmbH
K090466	DIGITAL RETINAL CAMERA, CR-1 MARK II	Mar 23, 2009	Substantially Equivalent	Canon, Inc.
K083771	RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP	Jan 30, 2009	Substantially Equivalent	Clarity Medical Systems
K083387	MODIFICATION TO KOWA NONMYD ALPHA-DIII	Jan 16, 2009	Substantially Equivalent	Kowa Co. , Ltd.
K081858	RETCAM 3 OPHTHALMIC IMAGING SYSTEM	Nov 05, 2008	Substantially Equivalent	Clarity Medical Systems
K082767	KOWA NONMYD ALPHA-DIII	Oct 21, 2008	Substantially Equivalent	Kowa Co. , Ltd.
K080180	MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)	Jun 11, 2008	Substantially Equivalent	Optical Imaging , Ltd.
K080883	CR-1	Apr 24, 2008	Substantially Equivalent	Canon, Inc.
K080681	KOWA GENESIS-D	Apr 04, 2008	Substantially Equivalent	Kowa Co. , Ltd.
K070231	ORION	Apr 24, 2007	Substantially Equivalent	Nidek Technologies Srl
K063717	CF-1	Jan 23, 2007	Substantially Equivalent	Canon, Inc.
K062416	RETINAL FUNCTIONAL IMAGER (RFI)	Nov 17, 2006	Substantially Equivalent	Optical Imaging , Ltd.
K062021	KOWA VX-10I	Nov 01, 2006	Substantially Equivalent	Kowa Co. , Ltd.
K062295	IRI INTEGRATED RETINAL IMAGER	Oct 20, 2006	Substantially Equivalent	Medivision Medical Imaging, Ltd.
K061768	MP-1 MICROPERIMETER	Sep 28, 2006	Substantially Equivalent	Nidek Technologies Srl
K062356	KOWA NONMYD ALPHA-D	Sep 27, 2006	Substantially Equivalent	Kowa Co. , Ltd.
K053044	OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5	Jan 24, 2006	Substantially Equivalent	Opto Global, Inc.
K053026	KOWA NONMYD 7, KOWA NONMYD A-D	Nov 10, 2005	Substantially Equivalent	Kowa Co. , Ltd.
K050271	KOWA GENESIS-D HAND-HELD RETINAL CAMERA	Nov 03, 2005	Substantially Equivalent	Kowa Co. , Ltd.
K052268	VISUCAM PRO NM	Nov 02, 2005	Substantially Equivalent	Carl Zeiss Meditec, AG
K043213	KOWA VX-10	Oct 06, 2005	Substantially Equivalent	Kowa Co. , Ltd.
K043222	VISCUCAM C DIGITAL CAMERA	Feb 14, 2005	Substantially Equivalent	Carl Zeiss Meditec, AG
K041367	TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA	Nov 05, 2004	Substantially Equivalent	Topcon Corp.
K041546	DIGITAL FUNDUS CAMERA, MODEL CF-60DSI	Jun 23, 2004	Substantially Equivalent	Canon, Inc.
K040325	PANORET, MODEL PNM 60	Mar 08, 2004	Substantially Equivalent	Medibell Medical Vision Technologies , Ltd.
K031629	CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI	Jun 06, 2003	Substantially Equivalent	Canon USA, Inc.
K023719	MP-1 MICRO PERIMETER	Dec 23, 2002	Substantially Equivalent	Nidek Technologies Srl
K020888	FUNDUS AUTOIMAGER	Nov 07, 2002	Substantially Equivalent	Visual Pathways, Inc.
K022164	ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM	Jul 26, 2002	Substantially Equivalent	Zeta Development Laboratories
K014274	NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000	Apr 17, 2002	Substantially Equivalent	Nidek, Inc.
K011877	FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM	Sep 26, 2001	Substantially Equivalent	Carl Zeiss Jena GmbH
K010315	ISCREEN VISION SCREENER	Jun 01, 2001	Substantially Equivalent	Iscreen, LLC
K002920	MEGAVISION CPX, MEGAVISION FA, MODEL I AND II	Dec 18, 2000	Substantially Equivalent	Escalon Medical Corp.
K003236	RETINADX	Nov 02, 2000	Substantially Equivalent	Regulatory Associates, Inc.
K001275	RETCAM II	Jul 13, 2000	Substantially Equivalent	Massie Research Laboratories, Inc.
K000368	EYECAP IMAGING SYSTEM	May 04, 2000	Substantially Equivalent	Clement Clarke Intl., Ltd.
K990205	DIGISCOPE OPHTHALMIC CAMERA	Mar 26, 1999	Substantially Equivalent	Eye Tel Imaging, Inc.
K982689	WINSTATION RETINAL IMAGER	Oct 23, 1998	Substantially Equivalent	Ophthalmic Imaging Systems
K974535	DISCAM DIGITAL IMAGING SYSTEM	Aug 14, 1998	Substantially Equivalent	Marcher Enterprises, Ltd.
K980295	OPHTHAVISION IMAGING SYSTEM	May 19, 1998	Substantially Equivalent	Mrp Group, Inc.
K980246	NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM	May 06, 1998	Substantially Equivalent	Canon USA, Inc.
K980357	KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER	Apr 24, 1998	Substantially Equivalent	Konan, Inc.
K973950	RETINAL CUBE	Dec 12, 1997	Substantially Equivalent	Applied Spectral Imaging , Ltd.
K973533	NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)	Nov 04, 1997	Substantially Equivalent	Nidek, Inc.
K973218	NIDEK HANDY	Nov 04, 1997	Substantially Equivalent	Nidek, Inc.
K972440	CATARACTSCREENER CT - S	Sep 30, 1997	Substantially Equivalent	Neitz Instruments Company, Ltd.
K971685	IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM	Jun 24, 1997	Substantially Equivalent	Tomey Corporation USA
K963333	OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)	Oct 22, 1996	Substantially Equivalent	Karl Storz Imaging, Inc.
K955442	KOWA SC-1200 PHOTO SLIT LAMP SYSTEM	Jan 03, 1996	Substantially Equivalent	Kowa Optimed, Inc.
K954781	KOWA GENESIS HAND-HELD FUNDUS CAMERA	Dec 01, 1995	Substantially Equivalent	Kowa Optimed, Inc.
K954780	KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C	Dec 01, 1995	Substantially Equivalent	Kowa Optimed, Inc.
K953973	ANGIOVISION 1000	Nov 17, 1995	Substantially Equivalent	Medivision Medical Imaging, Ltd.
K953972	ANGIOVISION VIEWING STATION	Nov 17, 1995	Substantially Equivalent	Medivision Medical Imaging, Ltd.
K952480	ORIMS DIGITAL ANGIOGRAPHY SYSTEM	Aug 25, 1995	Substantially Equivalent	Midwest Ophthalmic Instruments, Inc.
K941234	NON-MYDRIATIC RETINAL CAMERA	Jun 07, 1995	Substantially Equivalent	Canon USA, Inc.
K950091	KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000	Mar 01, 1995	Substantially Equivalent	Konan Medical, Inc.
K946058	60 FUNDUS CAMERA CF-60UV	Feb 03, 1995	Substantially Equivalent	Canon USA, Inc.
K934663	60 DEGREE FUNDUS CAMERA, CF-60UD	Feb 22, 1994	Substantially Equivalent	Canon USA, Inc.
K930442	MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS	Aug 09, 1993	Substantially Equivalent	Marco Ophthalmic, Inc.
K923708	LEMPERT OPTIC DISC ANALYSIS SYSTEM	Mar 19, 1993	Substantially Equivalent	Lempert Ophthalmic Instruments
K923958	CHROMOS IMAGER	Mar 04, 1993	Substantially Equivalent	Chromos Imaging, Inc.
K913314	CANDELA RETINAL CAMERA	Jan 23, 1992	Substantially Equivalent	Candela Laser Corp.
K913929	DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM	Nov 27, 1991	Substantially Equivalent	Ophthalmic Imaging Systems
K911439	NON-MYDRIATIC RETINAL CAMERA, CR-45UAF	Jun 17, 1991	Substantially Equivalent	Canon USA, Inc.
K895474	NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL	Oct 04, 1989	Substantially Equivalent	Canon USA, Inc.
K884989	NEVISCAN MODEL N - 100	Feb 28, 1989	Substantially Equivalent	Special Products, Inc.
K874355	OPACITY LENSMETER 701	Jan 26, 1988	Substantially Equivalent	Intraoptics, Inc.
K874017	MODIFIED RETINAL CAMERA MODEL CR4-45NM	Nov 02, 1987	Substantially Equivalent	Canon USA, Inc.
K873157	OXFORD RETRO-ILLUMINATION CATARACT CAMERA	Sep 30, 1987	Substantially Equivalent	Holofax , Ltd.
K862323	CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM	Aug 21, 1986	Substantially Equivalent	Canon USA, Inc.
K855170	CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM	Feb 27, 1986	Substantially Equivalent	Canon USA, Inc.
K854330	IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM	Dec 13, 1985	Substantially Equivalent	Par Technology Park
K852638	HUMPHREY IMAGE ANALYZER MODEL 110	Aug 12, 1985	Substantially Equivalent	Zeiss Humphrey System
K843899	GRC-WT, GRC-W	Jan 28, 1985	Substantially Equivalent	Olympus Corp.
K844898	CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM	Jan 22, 1985	Substantially Equivalent	Canon USA, Inc.
K843021	CANON 60 FUNDUS CAMERA CF-60U	Oct 05, 1984	Substantially Equivalent	Canon USA, Inc.
K833694	TEXAS BIO SCAN	Mar 02, 1984	Substantially Equivalent	Texas Bio Scan
K822991	AO DOCUSTAR(MMIRO) FUNDUS CAMERA	Feb 24, 1983	Substantially Equivalent	Warner-Lambert Co.
K823719	AML (ANGLE MAGNIFYING LENS	Jan 05, 1983	Substantially Equivalent	Nikon, Inc.
K822908	COHERENT FUNDUSL RETINAL CAMERA	Jan 05, 1983	Substantially Equivalent	Coherent Medical Division
K770888	POMERANTZEFF EQUATOR PLUS CAMERA	Jun 03, 1977	Substantially Equivalent	Medical Instrument Research Assoc., Inc.