FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
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 |
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 |
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 |
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 |
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 |