FDA Product Code
FDA Product Code HKI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1120
510(k) Clearances — 157 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040325 | PANORET, MODEL PNM 60 | Medibell Medical Vision Technologies , Ltd. | 2004-03-08 | Special | PDF ↗ |
| K031629 | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI | Canon USA, Inc. | 2003-06-06 | Traditional | PDF ↗ |
| K023719 | MP-1 MICRO PERIMETER | Nidek Technologies Srl | 2002-12-23 | Traditional | PDF ↗ |
| K020888 | FUNDUS AUTOIMAGER | Visual Pathways, Inc. | 2002-11-07 | Traditional | PDF ↗ |
| K022164 | ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM | Zeta Development Laboratories | 2002-07-26 | Traditional | PDF ↗ |
| K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | Nidek, Inc. | 2002-04-17 | Traditional | PDF ↗ |
| K011877 | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM | Carl Zeiss Jena GmbH | 2001-09-26 | Traditional | PDF ↗ |
| K010315 | ISCREEN VISION SCREENER | Iscreen, LLC | 2001-06-01 | Traditional | PDF ↗ |
| K002920 | MEGAVISION CPX, MEGAVISION FA, MODEL I AND II | Escalon Medical Corp. | 2000-12-18 | Traditional | PDF ↗ |
| K003236 | RETINADX | Regulatory Associates, Inc. | 2000-11-02 | Traditional | PDF ↗ |
| K001275 | RETCAM II | Massie Research Laboratories, Inc. | 2000-07-13 | Traditional | PDF ↗ |
| K000368 | EYECAP IMAGING SYSTEM | Clement Clarke Intl., Ltd. | 2000-05-04 | Traditional | PDF ↗ |
| K990205 | DIGISCOPE OPHTHALMIC CAMERA | Eye Tel Imaging, Inc. | 1999-03-26 | Traditional | PDF ↗ |
| K982689 | WINSTATION RETINAL IMAGER | Ophthalmic Imaging Systems | 1998-10-23 | Traditional | PDF ↗ |
| K974535 | DISCAM DIGITAL IMAGING SYSTEM | Marcher Enterprises, Ltd. | 1998-08-14 | Traditional | PDF ↗ |
| K980295 | OPHTHAVISION IMAGING SYSTEM | Mrp Group, Inc. | 1998-05-19 | Traditional | PDF ↗ |
| K980246 | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM | Canon USA, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980357 | KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER | Konan, Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K973950 | RETINAL CUBE | Applied Spectral Imaging , Ltd. | 1997-12-12 | Traditional | PDF ↗ |
| K973533 | NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) | Nidek, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K973218 | NIDEK HANDY | Nidek, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K972440 | CATARACTSCREENER CT - S | Neitz Instruments Company, Ltd. | 1997-09-30 | Traditional | PDF ↗ |
| K971685 | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM | Tomey Corporation USA | 1997-06-24 | Traditional | PDF ↗ |
| K963333 | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) | Karl Storz Imaging, Inc. | 1996-10-22 | Traditional | PDF ↗ |
| K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | Kowa Optimed, Inc. | 1996-01-03 | Traditional | PDF ↗ |
| K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C | Kowa Optimed, Inc. | 1995-12-01 | Traditional | PDF ↗ |
| K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA | Kowa Optimed, Inc. | 1995-12-01 | Traditional | PDF ↗ |
| K953972 | ANGIOVISION VIEWING STATION | Medivision Medical Imaging, Ltd. | 1995-11-17 | Traditional | PDF ↗ |
| K953973 | ANGIOVISION 1000 | Medivision Medical Imaging, Ltd. | 1995-11-17 | Traditional | PDF ↗ |
| K952480 | ORIMS DIGITAL ANGIOGRAPHY SYSTEM | Midwest Ophthalmic Instruments, Inc. | 1995-08-25 | Traditional | PDF ↗ |
| K941234 | NON-MYDRIATIC RETINAL CAMERA | Canon USA, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K950091 | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 | Konan Medical, Inc. | 1995-03-01 | Traditional | PDF ↗ |
| K946058 | 60 FUNDUS CAMERA CF-60UV | Canon USA, Inc. | 1995-02-03 | Traditional | PDF ↗ |
| K934663 | 60 DEGREE FUNDUS CAMERA, CF-60UD | Canon USA, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS | Marco Ophthalmic, Inc. | 1993-08-09 | Traditional | PDF ↗ |
| K923708 | LEMPERT OPTIC DISC ANALYSIS SYSTEM | Lempert Ophthalmic Instruments | 1993-03-19 | Traditional | PDF ↗ |
| K923958 | CHROMOS IMAGER | Chromos Imaging, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K913314 | CANDELA RETINAL CAMERA | Candela Laser Corp. | 1992-01-23 | Traditional | PDF ↗ |
| K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM | Ophthalmic Imaging Systems | 1991-11-27 | Traditional | PDF ↗ |
| K911439 | NON-MYDRIATIC RETINAL CAMERA, CR-45UAF | Canon USA, Inc. | 1991-06-17 | Traditional | PDF ↗ |
| K895474 | NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL | Canon USA, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K884989 | NEVISCAN MODEL N - 100 | Special Products, Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K874355 | OPACITY LENSMETER 701 | Intraoptics, Inc. | 1988-01-26 | Traditional | PDF ↗ |
| K874017 | MODIFIED RETINAL CAMERA MODEL CR4-45NM | Canon USA, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K873157 | OXFORD RETRO-ILLUMINATION CATARACT CAMERA | Holofax , Ltd. | 1987-09-30 | Traditional | PDF ↗ |
| K862323 | CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM | Canon USA, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K855170 | CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM | Canon USA, Inc. | 1986-02-27 | Traditional | PDF ↗ |
| K854330 | IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM | Par Technology Park | 1985-12-13 | Traditional | PDF ↗ |
| K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 | Zeiss Humphrey System | 1985-08-12 | Traditional | PDF ↗ |
| K843899 | GRC-WT, GRC-W | Olympus Corp. | 1985-01-28 | Traditional | PDF ↗ |
| K844898 | CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM | Canon USA, Inc. | 1985-01-22 | Traditional | PDF ↗ |
| K843021 | CANON 60 FUNDUS CAMERA CF-60U | Canon USA, Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K833694 | TEXAS BIO SCAN | Texas Bio Scan | 1984-03-02 | Traditional | PDF ↗ |
| K822991 | AO DOCUSTAR(MMIRO) FUNDUS CAMERA | Warner-Lambert Co. | 1983-02-24 | Traditional | PDF ↗ |
| K823719 | AML (ANGLE MAGNIFYING LENS | Nikon, Inc. | 1983-01-05 | Traditional | PDF ↗ |
| K822908 | COHERENT FUNDUSL RETINAL CAMERA | Coherent Medical Division | 1983-01-05 | Traditional | PDF ↗ |
| K770888 | POMERANTZEFF EQUATOR PLUS CAMERA | Medical Instrument Research Assoc., Inc. | 1977-06-03 | Traditional | PDF ↗ |
Product code HKI · Class II · Ophthalmic. Data: openFDA.