FDA 510(k) Applications for Medical Device Product Code "HKI"
(Camera, Ophthalmic, Ac-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K243664 | AI Optics | Sentinel Camera | 12/17/2024 |
| K973950 | APPLIED SPECTRAL IMAGING, LTD. | RETINAL CUBE | 12/12/1997 |
| K132987 | C.S.O. S.R.L. | COBRA FUNDUS CAMERA | 07/03/2014 |
| K092565 | CANON COMPONENTS, INC. | DIGITAL RETINAL CAMERA CX-1 | 03/18/2010 |
| K241049 | Canon Inc. | CANON Fundus Camera CR-10 (CR-10) | 05/15/2024 |
| K201122 | Canon Inc. | Canon non-mydriatic retinal camera CR series | 07/23/2020 |
| K041546 | CANON INC. | DIGITAL FUNDUS CAMERA, MODEL CF-60DSI | 06/23/2004 |
| K031629 | CANON U.S.A., INC. | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI | 06/06/2003 |
| K980246 | CANON U.S.A., INC. | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM | 05/06/1998 |
| K063717 | CANON, INC. | CF-1 | 01/23/2007 |
| K080883 | CANON, INC. | CR-1 | 04/24/2008 |
| K111612 | CANON, INC. | DIGITAL RETINAL CAMERA | 09/14/2011 |
| K090466 | CANON, INC. | DIGITAL RETINAL CAMERA, CR-1 MARK II | 03/23/2009 |
| K102013 | CANON, INC.-MEDICAL EQUIPMENT GROUP | DIGITAL RETINAL CAMERA | 10/29/2010 |
| K123208 | CANON, INC.-MEDICAL EQUIPMENT GROUP | DIGITAL RETINAL CAMERA | 03/19/2013 |
| K011877 | CARL ZEISS JENA GMBH | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM | 09/26/2001 |
| K043222 | CARL ZEISS MEDITEC AG | VISCUCAM C DIGITAL CAMERA | 02/14/2005 |
| K052268 | CARL ZEISS MEDITEC AG | VISUCAM PRO NM | 11/02/2005 |
| K101935 | CENTERVUE SPA | CENTERVUE DIGITAL RETINOGRAPHY SYSTEM | 10/27/2010 |
| K190954 | Chongqing Bio NewVision Medical Equipment Ltd. | Fundus Camera | 01/22/2020 |
| K090326 | CLARITY MEDICAL SYSTEMS | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | 11/25/2009 |
| K081858 | CLARITY MEDICAL SYSTEMS | RETCAM 3 OPHTHALMIC IMAGING SYSTEM | 11/05/2008 |
| K102859 | CLARITY MEDICAL SYSTEMS | RETCAM 3 OPTHALMIC IMAGING SYSTEM | 04/20/2011 |
| K083771 | CLARITY MEDICAL SYSTEMS | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | 01/30/2009 |
| K000368 | CLEMENT CLARKE INTL., LTD. | EYECAP IMAGING SYSTEM | 05/04/2000 |
| K210197 | Crystalvue Medical Corporation | NFC-600 Automated Portable Retinal Camera | 04/13/2021 |
| K182199 | Crystalvue Medical Corporation | NFC-700 non-mydriatic auto fundus camera | 01/02/2019 |
| K002920 | ESCALON MEDICAL CORP. | MEGAVISION CPX, MEGAVISION FA, MODEL I AND II | 12/18/2000 |
| K990205 | EYE TEL IMAGING, INC. | DIGISCOPE OPHTHALMIC CAMERA | 03/26/1999 |
| K161727 | EYENEZ LLC | Eyenez Ophthalmic Camera | 10/04/2016 |
| K102412 | EYEQUICK.LLC | VISTA DIGITAL OPTHALMOSCOPE | 06/23/2011 |
| K183059 | Forus Health Pvt. Ltd. | 3nethra neo | 12/21/2018 |
| K093071 | FUNDUS PHOTO, LLC | FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 | 11/17/2010 |
| K202097 | Huvitz Co., Ltd. | Fundus Camera | 02/02/2021 |
| K173474 | Ilooda Co., Ltd. | RetiCapture | 07/27/2018 |
| K082196 | IMEDOS GMBH | STATIC VESSEL ANALYZER | 06/16/2009 |
| K102651 | ISCREEN VISION, INC. | ISCREEN VISION SCREENER | 01/12/2011 |
| K010315 | ISCREEN, LLC. | ISCREEN VISION SCREENER | 06/01/2001 |
| K963333 | KARL STORZ IMAGING, INC. | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) | 10/22/1996 |
| K140450 | KEELER LIMITED | KEELER KAPTURE SOFTWARE | 06/17/2014 |
| K980357 | KONAN, INC. | KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER | 04/24/1998 |
| K080681 | KOWA CO. LTD. | KOWA GENESIS-D | 04/04/2008 |
| K050271 | KOWA CO. LTD. | KOWA GENESIS-D HAND-HELD RETINAL CAMERA | 11/03/2005 |
| K053026 | KOWA CO. LTD. | KOWA NONMYD 7, KOWA NONMYD A-D | 11/10/2005 |
| K062356 | KOWA CO. LTD. | KOWA NONMYD ALPHA-D | 09/27/2006 |
| K082767 | KOWA CO. LTD. | KOWA NONMYD ALPHA-DIII | 10/21/2008 |
| K101628 | KOWA CO. LTD. | KOWA NONMYD WX | 01/26/2011 |
| K043213 | KOWA CO. LTD. | KOWA VX-10 | 10/06/2005 |
| K091683 | KOWA CO. LTD. | KOWA VX-10 A | 07/02/2009 |
| K062021 | KOWA CO. LTD. | KOWA VX-10I | 11/01/2006 |
| K112330 | KOWA CO. LTD. | KOWA VX-20 | 02/16/2012 |
| K091098 | KOWA CO. LTD. | KOWAGENESIS-DF | 08/07/2009 |
| K083387 | KOWA CO. LTD. | MODIFICATION TO KOWA NONMYD ALPHA-DIII | 01/16/2009 |
| K190573 | Kowa Company, Ltd. | KOWA DR-1a | 06/04/2019 |
| K191945 | Kowa Company, Ltd. | KOWA nonmyd 8 | 09/10/2019 |
| K955442 | KOWA OPTIMED, INC. | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | 01/03/1996 |
| K202221 | Luneau Technology Operations | VX650 | 01/29/2021 |
| K974535 | MARCHER ENTERPRISES, LTD. | DISCAM DIGITAL IMAGING SYSTEM | 08/14/1998 |
| K001275 | MASSIE RESEARCH LABORATORIES, INC. | RETCAM II | 07/13/2000 |
| K040325 | MEDIBELL MEDICAL VISION TECHNOLOGIES LTD. | PANORET, MODEL PNM 60 | 03/08/2004 |
| K120982 | MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) | DIGITAL EYE-FUNDUS CAMERA | 09/28/2012 |
| K062295 | MEDIVISION MEDICAL IMAGING, LTD. | IRI INTEGRATED RETINAL IMAGER | 10/20/2006 |
| K980295 | MRP GROUP, INC. | OPHTHAVISION IMAGING SYSTEM | 05/19/1998 |
| K182263 | Natus Medical Incorporated | RetCam 3 ; RetCam Shuttle ; RetCam Portable | 09/07/2018 |
| K203500 | Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) | RetCam Envision | 04/13/2021 |
| K972440 | NEITZ INSTRUMENTS COMPANY, LTD. | CATARACTSCREENER CT - S | 09/30/1997 |
| K223575 | NeoLight, LLC | Phoenix ICON, Phoenix ICON GO | 09/06/2023 |
| K180306 | Next Sight srl | Nexy | 06/08/2018 |
| K190198 | Nidek Co., Ltd | Microperimeter MP-3, Microperimeter MP-3 Type S | 04/01/2019 |
| K152729 | NIDEK CO., LTD. | MICROPERIMETER MP-3 | 06/06/2016 |
| K023719 | NIDEK TECHNOLOGIES SRL | MP-1 MICRO PERIMETER | 12/23/2002 |
| K061768 | NIDEK TECHNOLOGIES SRL | MP-1 MICROPERIMETER | 09/28/2006 |
| K113451 | NIDEK TECHNOLOGIES SRL | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX | 05/08/2012 |
| K070231 | NIDEK TECHNOLOGIES SRL | ORION | 04/24/2007 |
| K973218 | NIDEK, INC. | NIDEK HANDY | 11/04/1997 |
| K973533 | NIDEK, INC. | NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) | 11/04/1997 |
| K014274 | NIDEK, INC. | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | 04/17/2002 |
| K092374 | OPHTHALMIC IMAGING SYSTEMS | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN | 11/17/2009 |
| K982689 | OPHTHALMIC IMAGING SYSTEMS | WINSTATION RETINAL IMAGER | 10/23/1998 |
| K250683 | Optain Health, Inc. | Resolve Fundus Camera | 04/30/2025 |
| K080180 | OPTICAL IMAGING LTD. | MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) | 06/11/2008 |
| K062416 | OPTICAL IMAGING LTD. | RETINAL FUNCTIONAL IMAGER (RFI) | 11/17/2006 |
| K200254 | Optina Diagnostics | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | 04/27/2020 |
| K231230 | Optina Diagnostics Inc. | Optina-4C (MHRC-C1N) | 12/05/2023 |
| K053044 | OPTO GLOBAL, INC | OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 | 01/24/2006 |
| K163021 | OPTOMED OY | HAAG-STREIT FUNDUS MODULE 300 | 04/11/2017 |
| K180378 | Optomed Oy | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | 04/05/2018 |
| K132186 | OPTOMED OY | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | 12/18/2013 |
| K110986 | OPTOMED OY | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 | 05/16/2011 |
| K092056 | OPTOMED OY | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | 10/01/2009 |
| K201325 | Optomed Oyj | Optomed Smartscope M5 with Optomed Smartscope FA | 11/20/2020 |
| K122572 | OPTOVUE, INC. | ICAM FUNDUS CAMERA | 01/11/2013 |
| K130656 | OPTOVUE, INC. | IFUSION | 07/03/2013 |
| K221329 | Phelcom Technologies | Eyer Retinal Camera NM-STD | 02/22/2023 |
| K170527 | Phoenix Technology Group, Inc. dba Phoenix Clinical | Phoenix Clinical ICON | 09/15/2017 |
| K003236 | REGULATORY ASSOCIATES, INC. | RETINADX | 11/02/2000 |
| K153239 | Softcare Co., Ltd | LSFG-NAVI | 05/12/2016 |
| K182506 | TearScience, Inc. | LipiScan Dynamic Meibomian Imager | 12/10/2018 |
| K152869 | TEARSCIENCE, INC. | LipiView II Ocular Surface Interferometer | 01/14/2016 |
| K091935 | TEARSCIENCE, INC. | LIPIVIEW OCULAR SURFACE INTERFEROMETER | 10/23/2009 |
| K122481 | TEARSCIENCE, INC. | LIPIVIEW OCULAR SURFACE INTERFEROMETER | 12/31/2012 |
| K971685 | TOMEY CORPORATION USA | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM | 06/24/1997 |
| K100207 | TOPCON CORP. | NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F | 02/12/2010 |
| K090115 | TOPCON CORP. | RETINA CAMERA TRC-NW7SF MARK II | 06/30/2009 |
| K041367 | TOPCON CORP. | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA | 11/05/2004 |
| K130289 | TOPCON CORP. | TRC-NW8 NON-MYDRIATIC RETINAL CAMERA | 05/10/2013 |
| K141325 | TOPCON CORP. | TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA | 10/23/2014 |
| K221111 | Topcon Corporation | Non-Mydriatic Retinal Camera NW500 | 08/29/2022 |
| K141481 | TOPCON CORPORATION | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA | 09/17/2014 |
| K123101 | TOPCON MEDICAL SYSTEMS, INC. | TRC-50DX RETINAL CAMERA | 06/05/2013 |
| K123460 | TOPCON MEDICAL SYSTEMS, INC. | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA | 02/06/2013 |
| K101861 | TRUEVISION SYSTEMS, INCORPORATED | TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM | 12/22/2010 |
| K111771 | UNITED INTEGRATED SERVICES CO., LTD. | NON-CONTACT TEAR FILM THERMOGRAGH | 11/30/2011 |
| K193319 | Vasoptic Medical Inc. | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | 06/01/2020 |
| K242508 | Verily Life Sciences, LLC | Verily Numetric Retinal Camera | 12/09/2024 |
| K020888 | VISUAL PATHWAYS, INC. | FUNDUS AUTOIMAGER | 11/07/2002 |
| K223381 | Welch Allyn, Inc. | iExaminer System with Panoptic Plus | 03/15/2023 |
| K121405 | WELCH ALLYN, INC. | PANOPTIC | 12/20/2012 |
| K022164 | ZETA DEVELOPMENT LABORATORIES | ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM | 07/26/2002 |
| K230627 | Zilia Inc. | Zilia Ocular FC (ZIL-10002) | 11/20/2023 |
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