Panels › Ophthalmic › Product code HLI · Class 2
Ophthalmoscope, Ac-Powered
Regulation 886.1570
0510(k)s in 12 months (87 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in HLI
| Company | 510(k)s | Recalls |
|---|---|---|
| Optovue, Inc. | 7 | 4 |
| Carl Zeiss Meditec, Inc. | 7 | 1 |
| Keeler Instruments, Inc. | 6 | 1 |
| Neitz Instruments Company, Ltd. | 7 | 0 |
| Heidelberg Engineering | 5 | 0 |
| Talia Technology , Ltd. | 5 | 0 |
| Welch Allyn, Inc. | 5 | 0 |
| Woodlyn, Inc. | 5 | 0 |
| American Medical Optics | 3 | 0 |
| Bioptigen, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2016 | K153080 | RTVue XR OCT Avanti with AngioVue Software Optovue, Inc. | HLI |
| Dec 2, 2015 | K150722 | EnFocus 2300, EnFocus 4400 Bioptigen, Inc. | HLI |
| Mar 4, 2015 | K142953 | OCT-Camera Optomedical Technologies GmbH, DE | HLI |
| Sep 17, 2014 | K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE Propper Manufacturing Co., Inc. | HLI |
| Apr 23, 2014 | K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT Centervue S.P.A., IT | HLI |
| Mar 26, 2014 | K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES Amico Diagnostic Incorporated | HLI |
| Mar 19, 2014 | K133892 | IVUE 500 Optovue, Inc. | HLI |
| Feb 26, 2013 | K123316 | HEINE OMEGA 500 Heine Optotechnik GmbH & Co. KG, DE | HLI |
| Jan 18, 2013 | K121739 | IVUE WITH NORMATIVE DATABASE Optovue, Inc. | HLI |
| May 11, 2012 | K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) Bioptigen, Inc. | HLI |
| Apr 3, 2012 | K120238 | RTVUE XR OCT Optovue, Inc. | HLI |
| Jul 8, 2011 | K111531 | RHA2020 Annidis Health Systems Corp., CA | HLI |
| Jun 3, 2011 | K103266 | ISTAND Optovue, Inc. | HLI |
| Feb 9, 2011 | K110205 | AAIO-7, AAIO WIRLESS Appasamy Associates, IN | HLI |
| Sep 15, 2010 | K101505 | RTVUE MODEL RTVUE 100 Optovue, Inc. | HLI |
| Jun 17, 2010 | K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 Optovue, Inc. | HLI |
| Jan 26, 2007 | K063378 | CIRRUS HD-OCT, MODEL 4000 Carl Zeiss Meditec, Inc. | HLI |
| Dec 13, 2006 | K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM Bioptigen, Inc. | HLI |
| Aug 23, 2006 | K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER Talia Technology , Ltd. | HLI |
| May 23, 2006 | K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE Keeler Instruments, Inc. | HLI |
| Sep 30, 2005 | K051789 | VISANTE OCT Carl Zeiss Meditec, Inc. | HLI |
| Jan 21, 2005 | K042885 | OCT-OPTHALMOSCOPE Ophthalmic Technologies, Inc. | HLI |
| Oct 7, 2004 | K042001 | PANORAMIC 200A Optos Plc. | HLI |
| May 24, 2004 | K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER Talia Technology , Ltd. | HLI |
| Apr 20, 2004 | K033123 | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE Carl Zeiss Meditec, Inc. | HLI |
| May 6, 2003 | K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER Talia Technology , Ltd. | HLI |
| May 1, 2003 | K030433 | STRATUSOCT WITH RNFL NORMATIVE DATABASE Carl Zeiss Meditec, Inc. | HLI |
| Jan 25, 2001 | K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE Welch Allyn, Inc. | HLI |
| Sep 20, 2000 | K994340 | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ Hai Laboratories, Inc. | HLI |
| Jun 21, 2000 | K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 Canon USA, Inc. | HLI |
| Mar 31, 2000 | K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER Talia Technology , Ltd. | HLI |
| Feb 3, 1999 | K983999 | PANORAMIC200 OPTHALMOSCOPE Optos Plc. | HLI |
| Aug 5, 1998 | K981640 | S2LO Odyssey Optical Systems, LLC | HLI |
| Jul 29, 1997 | K971671 | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) Heidelberg Engineering, DE | HLI |
| Mar 19, 1997 | K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE Mira, Inc. | HLI |
| Feb 3, 1997 | K964137 | RTA RETINAL THICKNESS ANALYZER Talia Technology , Ltd. | HLI |
| Jun 21, 1996 | K961171 | HUMPHREY OCT SCANNER Carl Zeiss, Inc. | HLI |
| Jun 26, 1995 | K951132 | ANGIOSCAN (AS STAND ALONE INSTRUMENT) Carl Zeiss Meditec, Inc. | HLI |
| Jun 6, 1995 | K951210 | WELCH ALLYN VIDEO OPHTHALMOSCOPE Welch Allyn, Inc. | HLI |
| Apr 7, 1995 | K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV Neitz Instruments Company, Ltd., JP | HLI |
| Apr 4, 1995 | K950461 | WELCH ALLYN OPHTHALMOSCOPE Welch Allyn, Inc. | HLI |
| Nov 14, 1994 | K944261 | RETINA ANGIOGRAPH Heidelberg Engineering, DE | HLI |
| Nov 14, 1994 | K943956 | RETINA TOMOGRAPH AND FLOWMETER Heidelberg Engineering, DE | HLI |
| Nov 14, 1994 | K943955 | RETINA FLOWMETER Heidelberg Engineering, DE | HLI |
| Aug 5, 1994 | K942720 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 Neitz Instruments Company, Ltd. | HLI |
| Aug 5, 1994 | K942715 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC Neitz Instruments Company, Ltd. | HLI |
| Aug 5, 1994 | K942714 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP Neitz Instruments Company, Ltd. | HLI |
| Aug 5, 1994 | K942713 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H Neitz Instruments Company, Ltd. | HLI |
| Aug 5, 1994 | K942712 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A Neitz Instruments Company, Ltd. | HLI |
| Aug 5, 1994 | K942711 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 Neitz Instruments Company, Ltd. | HLI |
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