Panels › Ophthalmic › Product code HKI · Class 2
Camera, Ophthalmic, Ac-Powered
Regulation 886.1120
3510(k)s in 12 months (157 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in HKI
| Company | 510(k)s | Recalls |
|---|---|---|
| Canon USA, Inc. | 19 | 0 |
| Kowa Co. , Ltd. | 14 | 0 |
| Clarity Medical Systems | 4 | 3 |
| Nidek Co., Ltd. | 5 | 2 |
| Topcon Corp. | 7 | 0 |
| Optomed OY | 5 | 0 |
| Nidek Technologies Srl | 4 | 0 |
| Tearscience, Inc. | 4 | 0 |
| Kowa Optimed, Inc. | 3 | 0 |
| Medivision Medical Imaging, Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 2013 | K122572 | ICAM FUNDUS CAMERA Optovue, Inc. | HKI |
| Dec 31, 2012 | K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER Tearscience, Inc. | HKI |
| Dec 20, 2012 | K121405 | PANOPTIC Welch Allyn, Inc. | HKI |
| Sep 28, 2012 | K120982 | DIGITAL EYE-FUNDUS CAMERA Medimaging Integrated Solutions, Inc. (Miis), CN | HKI |
| May 8, 2012 | K113451 | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX Nidek Technologies Srl, IT | HKI |
| Feb 16, 2012 | K112330 | KOWA VX-20 Kowa Co. , Ltd., JP | HKI |
| Nov 30, 2011 | K111771 | NON-CONTACT TEAR FILM THERMOGRAGH United Integrated Services Co., Ltd., TW | HKI |
| Sep 14, 2011 | K111612 | DIGITAL RETINAL CAMERA Canon, Inc., JP | HKI |
| Jun 23, 2011 | K102412 | VISTA DIGITAL OPTHALMOSCOPE Eyequick.Llc | HKI |
| May 16, 2011 | K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 Optomed OY, FI | HKI |
| Apr 20, 2011 | K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM Clarity Medical Systems | HKI |
| Jan 26, 2011 | K101628 | KOWA NONMYD WX Kowa Co. , Ltd., JP | HKI |
| Jan 12, 2011 | K102651 | ISCREEN VISION SCREENER Iscreen Vision, Inc. | HKI |
| Dec 22, 2010 | K101861 | TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM Truevision Systems, Incorporated | HKI |
| Nov 17, 2010 | K093071 | FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 Fundus Photo, LLC | HKI |
| Oct 29, 2010 | K102013 | DIGITAL RETINAL CAMERA Canon Inc. -Medical Equipment Group, JP | HKI |
| Oct 27, 2010 | K101935 | CENTERVUE DIGITAL RETINOGRAPHY SYSTEM Centervue S.P.A., IT | HKI |
| Mar 18, 2010 | K092565 | DIGITAL RETINAL CAMERA CX-1 Canon Components, Inc. | HKI |
| Feb 12, 2010 | K100207 | NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F Topcon Corp., JP | HKI |
| Nov 25, 2009 | K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS Clarity Medical Systems | HKI |
| Nov 17, 2009 | K092374 | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN Ophthalmic Imaging Systems | HKI |
| Oct 23, 2009 | K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER Tearscience, Inc. | HKI |
| Oct 1, 2009 | K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 Optomed OY, FI | HKI |
| Aug 7, 2009 | K091098 | KOWAGENESIS-DF Kowa Co. , Ltd., JP | HKI |
| Jul 2, 2009 | K091683 | KOWA VX-10 A Kowa Co. , Ltd., JP | HKI |
| Jun 30, 2009 | K090115 | RETINA CAMERA TRC-NW7SF MARK II Topcon Corp., JP | HKI |
| Jun 16, 2009 | K082196 | STATIC VESSEL ANALYZER Imedos GmbH | HKI |
| Mar 23, 2009 | K090466 | DIGITAL RETINAL CAMERA, CR-1 MARK II Canon, Inc. | HKI |
| Jan 30, 2009 | K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP Clarity Medical Systems | HKI |
| Jan 16, 2009 | K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII Kowa Co. , Ltd., JP | HKI |
| Nov 5, 2008 | K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM Clarity Medical Systems | HKI |
| Oct 21, 2008 | K082767 | KOWA NONMYD ALPHA-DIII Kowa Co. , Ltd., JP | HKI |
| Jun 11, 2008 | K080180 | MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) Optical Imaging , Ltd. | HKI |
| Apr 24, 2008 | K080883 | CR-1 Canon, Inc. | HKI |
| Apr 4, 2008 | K080681 | KOWA GENESIS-D Kowa Co. , Ltd., JP | HKI |
| Apr 24, 2007 | K070231 | ORION Nidek Technologies Srl, IT | HKI |
| Jan 23, 2007 | K063717 | CF-1 Canon, Inc. | HKI |
| Nov 17, 2006 | K062416 | RETINAL FUNCTIONAL IMAGER (RFI) Optical Imaging , Ltd. | HKI |
| Nov 1, 2006 | K062021 | KOWA VX-10I Kowa Co. , Ltd. | HKI |
| Oct 20, 2006 | K062295 | IRI INTEGRATED RETINAL IMAGER Medivision Medical Imaging, Ltd., IL | HKI |
| Sep 28, 2006 | K061768 | MP-1 MICROPERIMETER Nidek Technologies Srl, IT | HKI |
| Sep 27, 2006 | K062356 | KOWA NONMYD ALPHA-D Kowa Co. , Ltd., JP | HKI |
| Jan 24, 2006 | K053044 | OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 Opto Global, Inc. | HKI |
| Nov 10, 2005 | K053026 | KOWA NONMYD 7, KOWA NONMYD A-D Kowa Co. , Ltd., JP | HKI |
| Nov 3, 2005 | K050271 | KOWA GENESIS-D HAND-HELD RETINAL CAMERA Kowa Co. , Ltd., JP | HKI |
| Nov 2, 2005 | K052268 | VISUCAM PRO NM Carl Zeiss Meditec, AG | HKI |
| Oct 6, 2005 | K043213 | KOWA VX-10 Kowa Co. , Ltd. | HKI |
| Feb 14, 2005 | K043222 | VISCUCAM C DIGITAL CAMERA Carl Zeiss Meditec, AG | HKI |
| Nov 5, 2004 | K041367 | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA Topcon Corp. | HKI |
| Jun 23, 2004 | K041546 | DIGITAL FUNDUS CAMERA, MODEL CF-60DSI Canon, Inc. | HKI |
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