Atlas FDA

HLI

87 FDA 510(k) clearances · Product code

88 daysmedian time to decision
219 days90th percentile
87clearances measured

FDA profile

Official device name
Ophthalmoscope, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Medical specialty
Ophthalmic
Adverse events (MAUDE)
1998: 1 · 2001: 4 · 2004: 3 · 2005: 4 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RTVue XR OCT Avanti with AngioVue Software (K153080)Optovue, Inc.2016-02-11
EnFocus 2300, EnFocus 4400 (K150722)Bioptigen, Inc.2015-12-02
OCT-Camera (K142953)Optomedical Technologies GmbH2015-03-04
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (K141638)Propper Manufacturing Co., Inc.2014-09-17
CENTERVUE MACULAR INTEGRITY ASSESSMENT (K133758)Centervue S.P.A.2014-04-23
AMICO DH-W35 OPHTHALMOSCOPE SERIES (K131939)Amico Diagnostic Incorporated2014-03-26
IVUE 500 (K133892)Optovue, Inc.2014-03-19
HEINE OMEGA 500 (K123316)Heine Optotechnik GmbH & Co. KG2013-02-26
IVUE WITH NORMATIVE DATABASE (K121739)Optovue, Inc.2013-01-18
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (K120057)Bioptigen, Inc.2012-05-11
RTVUE XR OCT (K120238)Optovue, Inc.2012-04-03
RHA2020 (K111531)Annidis Health Systems Corp.2011-07-08
ISTAND (K103266)Optovue, Inc.2011-06-03
AAIO-7, AAIO WIRLESS (K110205)Appasamy Associates2011-02-09
RTVUE MODEL RTVUE 100 (K101505)Optovue, Inc.2010-09-15
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 (K100861)Optovue, Inc.2010-06-17
CIRRUS HD-OCT, MODEL 4000 (K063378)Carl Zeiss Meditec, Inc.2007-01-26
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (K063343)Bioptigen, Inc.2006-12-13
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER (K061674)Talia Technology , Ltd.2006-08-23
VANTAGE INDIRECT OPHTHALMOSCOPE (K060822)Keeler Instruments, Inc.2006-05-23
VISANTE OCT (K051789)Carl Zeiss Meditec, Inc.2005-09-30
OCT-OPTHALMOSCOPE (K042885)Ophthalmic Technologies, Inc.2005-01-21
PANORAMIC 200A (K042001)Optos Plc.2004-10-07
RTA MODEL D RETINAL THICKNESS ANALYZER (K041290)Talia Technology , Ltd.2004-05-24
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE (K033123)Carl Zeiss Meditec, Inc.2004-04-20
RTA MODEL D RETINAL THICKNESS ANALYZER (K031312)Talia Technology , Ltd.2003-05-06
STRATUSOCT WITH RNFL NORMATIVE DATABASE (K030433)Carl Zeiss Meditec, Inc.2003-05-01
WELCH ALLYN 11800 OPTHALMOSCOPE (K003376)Welch Allyn, Inc.2001-01-25
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ (K994340)Hai Laboratories, Inc.2000-09-20
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 (K992606)Canon USA, Inc.2000-06-21
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER (K000731)Talia Technology , Ltd.2000-03-31
PANORAMIC200 OPTHALMOSCOPE (K983999)Optos Plc.1999-02-03
S2LO (K981640)Odyssey Optical Systems, LLC1998-08-05
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) (K971671)Heidelberg Engineering1997-07-29
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE (K951728)Mira, Inc.1997-03-19
RTA RETINAL THICKNESS ANALYZER (K964137)Talia Technology , Ltd.1997-02-03
HUMPHREY OCT SCANNER (K961171)Carl Zeiss, Inc.1996-06-21
ANGIOSCAN (AS STAND ALONE INSTRUMENT) (K951132)Carl Zeiss Meditec, Inc.1995-06-26
WELCH ALLYN VIDEO OPHTHALMOSCOPE (K951210)Welch Allyn, Inc.1995-06-06
INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV (K951338)Neitz Instruments Company, Ltd.1995-04-07
WELCH ALLYN OPHTHALMOSCOPE (K950461)Welch Allyn, Inc.1995-04-04
RETINA ANGIOGRAPH (K944261)Heidelberg Engineering1994-11-14
RETINA FLOWMETER (K943955)Heidelberg Engineering1994-11-14
RETINA TOMOGRAPH AND FLOWMETER (K943956)Heidelberg Engineering1994-11-14
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC (K942715)Neitz Instruments Company, Ltd.1994-08-05
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H (K942713)Neitz Instruments Company, Ltd.1994-08-05
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A (K942712)Neitz Instruments Company, Ltd.1994-08-05
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP (K942714)Neitz Instruments Company, Ltd.1994-08-05
NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 (K942711)Neitz Instruments Company, Ltd.1994-08-05
NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 (K942720)Neitz Instruments Company, Ltd.1994-08-05
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE (K942104)Keeler Instruments, Inc.1994-08-04
NERVE FIBER ANALYZER (K941705)Carl Zeiss Meditec, Inc.1994-07-18
R&D BATTERIES # 5615, 5234, 5097 (K935988)R & D Batteries, Inc.1994-02-22
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE (K930023)Welch Allyn, Inc.1993-06-21
TOPOGRAPHIC SCANNING SYSTEM TOPSS (K923742)Carl Zeiss Meditec, Inc.1993-03-26
REGALTECH MAXISCOPE (K921163)Regaltech Pty. , Ltd.1992-10-27
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE (K914484)Hgm Medical Laser Systems, Inc.1992-01-06
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) (K912581)Carl Zeiss, Inc.1991-12-23
PROFESSIONAL INDIRECT OPHTHALMOSCOPE (K912397)Clement Clarke, Inc.1991-10-23
GLAUCOMA-SCOPE (K913118)Ophthalmic Imaging Systems1991-10-09
HEIDELBERG RETINA TOMOGRAPH (K912891)Heidelberg Engineering1991-09-27
KEELER KONAN SPECULAR MICROSCOPE SP3300 (K900111)Keeler Instruments, Inc.1990-03-23
MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (K895010)Mentor O & O, Inc.1989-09-11
VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) (K893173)Keeler Instruments, Inc.1989-06-05
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) (K893172)Keeler Instruments, Inc.1989-06-05
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE (K882517)Rodenstock Instrument Corp.1989-01-24
EOL, MODEL LIO (K881984)Eol, Inc.1988-09-06
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE (K871268)G. Rodenstock Instrumente GmbH1987-06-10
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE (K854244)Keeler Instruments, Inc.1985-11-12
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (K851264)American Medical Optics1985-05-01
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (K851263)American Medical Optics1985-05-01
AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA (K851262)American Medical Optics1985-04-30
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE (K843596)Nidek, Inc.1985-02-15
MONOCULAR DIRECT OPHTHALMOSCOPE (K844971)Nidek, Inc.1985-02-15
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE (K843597)Nidek, Inc.1985-02-15
CANON AUTO KERATOMETER K-1 (K844054)Canon USA, Inc.1984-12-19
WOODLYN CLASSIC CATARACT ACUITY TEST (K843812)Woodlyn, Inc.1984-12-11
BINOCULAR INDIRECT OPHTHALMOSCOPE (K843304)Mentor O & O, Inc.1984-11-21
MAMIYA SLIT LAMP P-1 (K843099)Okada Corp.1984-11-21
WOODLYN CLASSIC KERATOMETER (K841767)Woodlyn, Inc.1984-08-07
WOODLYN CLASSIC JAVAL OPHTHALMOMETER (K841764)Woodlyn, Inc.1984-08-07
WOODLYN CLASSIC SLIT LAMP HSSL-CL (K841761)Woodlyn, Inc.1984-08-07
WOODLYN SLIT LAMP HSSL-EC (K841763)Woodlyn, Inc.1984-08-02
ALCON INDIRECT OPHTHALMOSCOPE (K822104)Alcon Laboratories1982-08-10
BLUE FIELD ENTOPTOSCOPE BFE100 (K791510)Medical Instrument Research Assoc., Inc.1979-12-11
OPHTHALMOSCOPE, BINOCULAR, INDIRECT (K772214)Varian Assoc., Inc.1977-12-13
OPHTHALMOSCOPE, MODEL #11100 (K770768)Welch Allyn, Inc.1977-05-06

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