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 |
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 |
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 |
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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