FDA 510(k) Applications for Medical Device Product Code "NFJ"
(System, Image Management, Ophthalmic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K232088 | Altris, Inc. | Altris IMS | 07/31/2023 |
| K201273 | Canon Inc. | ImageSPECTRUM | 09/25/2020 |
| K173689 | Canon Inc. -Medical Equipment Group | Ophthalmic Software Platform RX | 02/23/2018 |
| K123464 | CARL ZEISS MEDITEC AG | CALLISTO EYE | 03/05/2013 |
| K232944 | Carl Zeiss Meditec AG | CALLISTO eye | 12/21/2023 |
| K180858 | Carl Zeiss Meditec AG | CALLISTO eye | 06/27/2018 |
| K231676 | Carl Zeiss Meditec AG | CALLISTO eye | 08/28/2023 |
| K213527 | Carl Zeiss Meditec AG | FORUM | 08/15/2022 |
| K122938 | CARL ZEISS MEDITEC AG | FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH | 11/02/2012 |
| K130648 | CARL ZEISS MEDITEC AG | FORUM GLAUCOMA WORKPLACE | 07/23/2013 |
| K141297 | CARL ZEISS MEDITEC AG | FORUM GLAUCOMA WORKPLACE | 10/03/2014 |
| K150467 | CARL ZEISS MEDITEC AG | Retina Workplace | 05/21/2015 |
| K170638 | Carl Zeiss Meditec AG | Retina Workplace | 06/21/2017 |
| K182318 | Carl Zeiss Meditec, Inc | Retina Workplace | 10/24/2018 |
| K090439 | CARL ZEISS MEDITEC, INC. | FORUM | 03/25/2009 |
| K234076 | Centervue Spa | iCare ALTIUS CW | 08/22/2024 |
| K110869 | DIAGNOS, INC | CARA | 07/14/2011 |
| K071299 | DIGITAL HEALTHCARE, LTD. | IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP | 08/31/2007 |
| K090266 | EYEIC CORPORATION | MATCHEDFLICKER | 05/06/2009 |
| K130453 | EYEKOR, LLC. | EXCELSIOR | 04/02/2013 |
| K142423 | HAAG-STREIT AG | EyeSuite Imaging | 09/10/2014 |
| K191615 | Huvitz Co., Ltd. | Huvitz Imaging System | 07/18/2019 |
| K161829 | HUVITZ CO., LTD. | Huvitz Imaging System | 04/06/2017 |
| K200385 | Integrated Ophthalmic Systems, Inc. | CONTINUUM PACS | 03/16/2020 |
| K141922 | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | 02/27/2015 |
| K203244 | Konan Medical, Inc. | CellChek 20 rc | 06/15/2021 |
| K081797 | KONAN MEDICAL, INC. | IMAGE STORAGE SYSTEM, MODEL KSS-400 | 01/22/2009 |
| K190056 | KOWA Co. Ltd. CHOFU | KOWA VK-2s | 02/12/2019 |
| K220929 | Merit CRO, Inc. | Excelsior | 10/31/2022 |
| K181501 | NeuroVision Imaging, LLC | Afina | 11/02/2018 |
| K181345 | Nidek Co., Ltd | Image Filing Software NAVIS-EX | 07/19/2018 |
| K013694 | NIDEK, INC. | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) | 11/19/2002 |
| K110006 | OPHTHALMIC IMAGING SYSTEMS | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | 05/18/2011 |
| K200275 | Ophthalmic Labs, Inc. | OVision Imaging System | 03/03/2020 |
| K113696 | OPTOS PLC | OPTOS ADVANCE | 05/25/2012 |
| K162039 | Optos Plc | OptosAdvance 4.0 Software | 02/08/2017 |
| K211715 | RetinAI Medical AG | RetinAI Discovery | 04/28/2022 |
| K171098 | Sonomed, Inc. | AXIS Image Management System | 05/02/2017 |
| K082364 | TOPCON CORP. | IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR | 09/30/2008 |
| K171370 | Topcon Corporation | IMAGEnet 6 Ophthalmic Data System | 11/01/2017 |
| K232828 | Topcon Corporation | IMAGEnet6 Ophthalmic Data System | 03/01/2024 |
| K232555 | Topcon Healthcare Solutions | Harmony | 11/20/2023 |
| K210396 | Topcon Healthcare Solutions EMEA Oy | Harmony Referral System | 09/13/2021 |
| K200954 | Topcon Healthcare Solutions, Inc. | Glaucoma Module | 08/03/2020 |
| K182376 | Topcon Medical Systems, Inc. | Harmony | 09/28/2018 |
| K132438 | TOPCON MEDICAL SYSTEMS, INC. | IMAGENET 5 PC SOFTWARE SYSTEM | 10/17/2013 |
| K093313 | TOPCON MEDICAL SYSTEMS, INC. | SYNERGY | 12/02/2009 |
| K151952 | TOPCON MEDICAL SYSTEMS, INC. | Synergy ODM | 10/01/2015 |
| K132667 | TOPCON MEDICAL SYSTEMS, INC. | SYNERGY ODM | 10/09/2013 |
| K200422 | VisionQuest BioMedical, Inc. | Image Quality Analyzer (IQA) | 12/24/2020 |
| K181016 | Welch Allyn, Inc. | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | 07/16/2018 |
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