FDA 510(k) Applications for Medical Device Product Code "OBO"
(Tomography, Optical Coherence)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K162783 | Bioptigen, Inc. | EnFocus 2300, EnFocus 4400 | 12/09/2016 |
| K221601 | C.S.O. S.r.l. | MS-39 | 09/01/2023 |
| K182942 | Canon Inc. | Canon OCT-A1 | 07/24/2019 |
| K133217 | CARL ZEISS MEDITEC AG | CIRRUS PHOTO | 03/19/2014 |
| K233421 | Carl Zeiss Meditec AG | RESCAN 700 | 03/08/2024 |
| K141844 | CARL ZEISS MEDITEC AG | RESCAN 700, CALLISTO EYE | 11/18/2014 |
| K180229 | Carl Zeiss Meditec AG | RESCAN 700, CALLISTO eye | 01/11/2019 |
| K150977 | CARL ZEISS MEDITEC INC | CIRRUS HD-OCT | 09/01/2015 |
| K222200 | Carl Zeiss Meditec Inc | CIRRUS HD-OCT | 04/13/2023 |
| K083291 | CARL ZEISS MEDITEC INC | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 | 05/05/2009 |
| K111157 | CARL ZEISS MEDITEC INC | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES | 01/19/2012 |
| K112184 | CARL ZEISS MEDITEC INC | CIRRUS PHOTO | 06/18/2012 |
| K233933 | Carl Zeiss Meditec Inc | CIRRUSÖ HD-OCT Model 6000 | 05/17/2024 |
| K181534 | Carl Zeiss Meditec, Inc. | CIRRUS HD-OCT | 02/15/2019 |
| K161194 | CARL ZEISS MEDITEC, INC. | PLEX Elite 9000 SS-OCT | 10/26/2016 |
| K163195 | Carl Zeiss Suzhou Co., Ltd. | PRIMUS | 06/21/2017 |
| K063191 | HEIDELBERG ENGINEERING | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT | 10/31/2006 |
| K101223 | HEIDELBERG ENGINEERING | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA | 10/01/2010 |
| K230897 | Heidelberg Engineering GmbH | Anterion | 10/11/2023 |
| K240924 | Heidelberg Engineering GmbH | Anterion | 12/13/2024 |
| K211817 | Heidelberg Engineering GmbH | Anterion | 11/05/2021 |
| K113129 | HEIDELBERG ENGINEERING GMBH | SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) | 11/08/2011 |
| K173648 | Heidelberg Engineering GmbH | Spectralis HRA + OCT and variants | 08/30/2018 |
| K152205 | Heidelberg Engineering GmbH | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor | 05/06/2016 |
| K121993 | HEIDELBERG ENGINEERING GMBH | SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT | 10/25/2012 |
| K172649 | Heidelberg Engineering GmbH | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor | 11/01/2017 |
| K223557 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants | 10/20/2023 |
| K250868 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants | 05/12/2025 |
| K240221 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants | 07/01/2024 |
| K192391 | Heidelberg Engineering GmbH | Spectralis HRA+OCT and Variants | 09/26/2019 |
| K201252 | Heidelberg Engineering GmbH | Spectralis HRA+OCT and variants | 09/09/2020 |
| K182569 | Heidelberg Engineering GmbH | Spectralis HRA+OCT and variants with High Magnification Module | 10/18/2018 |
| K181594 | Heidelberg Engineering GmbH | Spectralis HRA+OCT and variants with OCT Angiography Module | 09/13/2018 |
| K241163 | Heidelberg Engineering GmbH | SPECTRALIS with Flex Module | 10/11/2024 |
| K121622 | NIDEK CO., LTD. | NIDEK RS-3000 | 03/14/2013 |
| K132323 | NIDEK CO., LTD. | RS-3000 ADVANCE | 02/19/2014 |
| K221320 | Nidek Co., LTD. | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | 03/30/2023 |
| K080460 | OPKO HEALTH, INC. | SPECTRAL OCT/SLO | 11/14/2008 |
| K200516 | OptoMedical Technologies GmbH | OCT-Camera ID 21101A3 | 09/02/2020 |
| K121043 | OPTOS PLC | OPTOS OCT/SLO MICROPERIMETER | 02/22/2013 |
| K173707 | Optos plc | P200TE | 02/28/2018 |
| K231673 | Optos Plc | P200TE (A10700) | 08/18/2023 |
| K233602 | Optos Plc | P200TE (A10700) | 05/09/2024 |
| K190732 | Optos Plc | P200TxE | 07/31/2019 |
| K180660 | Optovue, Inc. | Avanti | 06/08/2018 |
| K071250 | OPTOVUE, INC. | CA, MODEL: CAM | 09/28/2007 |
| K163475 | Optovue, Inc. | iVue | 06/09/2017 |
| K091404 | OPTOVUE, INC. | IVUE, MODEL 100 | 04/22/2010 |
| K062552 | OPTOVUE, INC. | RTVUE | 10/06/2006 |
| K111505 | OPTOVUE, INC. | RTVUE CAM WITH CORNEAL POWER UPGRADE | 09/08/2011 |
| K222166 | Optovue, Inc. | SOLIX | 11/09/2022 |
| K071839 | REICHERT, INC. | SOCT COPERNICUS, MODEL 15205 | 02/27/2008 |
| K250553 | TOMEY Corporation | Tomey Cornea/Anterior Segment OCT (CASIA2) | 07/18/2025 |
| K213265 | Tomey Corporation | Tomey Cornea/Anterior Segment OCT CASIA2 | 04/27/2022 |
| K092470 | TOPCON CORP. | OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 | 09/02/2009 |
| K063388 | TOPCON CORP. | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM | 06/22/2007 |
| K161509 | Topcon Corporation | 3D OCT-1 Maestro | 07/28/2016 |
| K170164 | Topcon Corporation | 3D OCT-1 Maestro | 03/03/2017 |
| K233561 | Topcon Corporation | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | 04/10/2024 |
| K241081 | Topcon Corporation | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | 07/17/2024 |
| K231222 | Topcon Corporation | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | 10/30/2023 |
| K173119 | Topcon Corporation | DRI OCT Triton | 01/19/2018 |
| K083316 | TOPCON MEDICAL SYSTEMS, INC. | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM | 03/13/2009 |
| K072971 | TOPCON MEDICAL SYSTEMS, INC. | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS | 01/13/2009 |
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