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 |
|---|---|---|---|
| Mar 8, 2004 | K040325 | PANORET, MODEL PNM 60 Medibell Medical Vision Technologies , Ltd., IL | HKI |
| Jun 6, 2003 | K031629 | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI Canon USA, Inc. | HKI |
| Dec 23, 2002 | K023719 | MP-1 MICRO PERIMETER Nidek Technologies Srl, IT | HKI |
| Nov 7, 2002 | K020888 | FUNDUS AUTOIMAGER Visual Pathways, Inc. | HKI |
| Jul 26, 2002 | K022164 | ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM Zeta Development Laboratories | HKI |
| Apr 17, 2002 | K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 Nidek, Inc. | HKI |
| Sep 26, 2001 | K011877 | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM Carl Zeiss Jena GmbH | HKI |
| Jun 1, 2001 | K010315 | ISCREEN VISION SCREENER Iscreen, LLC | HKI |
| Dec 18, 2000 | K002920 | MEGAVISION CPX, MEGAVISION FA, MODEL I AND II Escalon Medical Corp. | HKI |
| Nov 2, 2000 | K003236 | RETINADX Regulatory Associates, Inc. | HKI |
| Jul 13, 2000 | K001275 | RETCAM II Massie Research Laboratories, Inc. | HKI |
| May 4, 2000 | K000368 | EYECAP IMAGING SYSTEM Clement Clarke Intl., Ltd., GB | HKI |
| Mar 26, 1999 | K990205 | DIGISCOPE OPHTHALMIC CAMERA Eye Tel Imaging, Inc. | HKI |
| Oct 23, 1998 | K982689 | WINSTATION RETINAL IMAGER Ophthalmic Imaging Systems | HKI |
| Aug 14, 1998 | K974535 | DISCAM DIGITAL IMAGING SYSTEM Marcher Enterprises, Ltd., GB | HKI |
| May 19, 1998 | K980295 | OPHTHAVISION IMAGING SYSTEM Mrp Group, Inc. | HKI |
| May 6, 1998 | K980246 | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM Canon USA, Inc. | HKI |
| Apr 24, 1998 | K980357 | KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER Konan, Inc. | HKI |
| Dec 12, 1997 | K973950 | RETINAL CUBE Applied Spectral Imaging , Ltd., IL | HKI |
| Nov 4, 1997 | K973533 | NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) Nidek, Inc. | HKI |
| Nov 4, 1997 | K973218 | NIDEK HANDY Nidek, Inc. | HKI |
| Sep 30, 1997 | K972440 | CATARACTSCREENER CT - S Neitz Instruments Company, Ltd., JP | HKI |
| Jun 24, 1997 | K971685 | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM Tomey Corporation USA | HKI |
| Oct 22, 1996 | K963333 | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) Karl Storz Imaging, Inc. | HKI |
| Jan 3, 1996 | K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM Kowa Optimed, Inc. | HKI |
| Dec 1, 1995 | K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA Kowa Optimed, Inc. | HKI |
| Dec 1, 1995 | K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C Kowa Optimed, Inc. | HKI |
| Nov 17, 1995 | K953973 | ANGIOVISION 1000 Medivision Medical Imaging, Ltd. | HKI |
| Nov 17, 1995 | K953972 | ANGIOVISION VIEWING STATION Medivision Medical Imaging, Ltd. | HKI |
| Aug 25, 1995 | K952480 | ORIMS DIGITAL ANGIOGRAPHY SYSTEM Midwest Ophthalmic Instruments, Inc. | HKI |
| Jun 7, 1995 | K941234 | NON-MYDRIATIC RETINAL CAMERA Canon USA, Inc. | HKI |
| Mar 1, 1995 | K950091 | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 Konan Medical, Inc., JP | HKI |
| Feb 3, 1995 | K946058 | 60 FUNDUS CAMERA CF-60UV Canon USA, Inc. | HKI |
| Feb 22, 1994 | K934663 | 60 DEGREE FUNDUS CAMERA, CF-60UD Canon USA, Inc. | HKI |
| Aug 9, 1993 | K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS Marco Ophthalmic, Inc. | HKI |
| Mar 19, 1993 | K923708 | LEMPERT OPTIC DISC ANALYSIS SYSTEM Lempert Ophthalmic Instruments | HKI |
| Mar 4, 1993 | K923958 | CHROMOS IMAGER Chromos Imaging, Inc. | HKI |
| Jan 23, 1992 | K913314 | CANDELA RETINAL CAMERA Candela Laser Corp. | HKI |
| Nov 27, 1991 | K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM Ophthalmic Imaging Systems | HKI |
| Jun 17, 1991 | K911439 | NON-MYDRIATIC RETINAL CAMERA, CR-45UAF Canon USA, Inc., JP | HKI |
| Oct 4, 1989 | K895474 | NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL Canon USA, Inc., JP | HKI |
| Feb 28, 1989 | K884989 | NEVISCAN MODEL N - 100 Special Products, Inc. | HKI |
| Jan 26, 1988 | K874355 | OPACITY LENSMETER 701 Intraoptics, Inc. | HKI |
| Nov 2, 1987 | K874017 | MODIFIED RETINAL CAMERA MODEL CR4-45NM Canon USA, Inc. | HKI |
| Sep 30, 1987 | K873157 | OXFORD RETRO-ILLUMINATION CATARACT CAMERA Holofax , Ltd., GB | HKI |
| Aug 21, 1986 | K862323 | CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM Canon USA, Inc. | HKI |
| Feb 27, 1986 | K855170 | CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM Canon USA, Inc. | HKI |
| Dec 13, 1985 | K854330 | IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM Par Technology Park | HKI |
| Aug 12, 1985 | K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 Zeiss Humphrey System | HKI |
| Jan 28, 1985 | K843899 | GRC-WT, GRC-W Olympus Corp. | HKI |
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