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Panels › Radiology › Product code NFJ · Class 2

System, Image Management, Ophthalmic

Regulation 892.2050

2510(k)s in 12 months (53 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
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Top companies in NFJ

Company510(k)sRecalls
Carl Zeiss Meditec, AG131
Topcon Medical Systems, Inc.53
Merge Healthcare, Inc.04
Topcon Corp.30
Bausch & Lomb Inc02
Diagnos, Inc.11
Haag-Streit AG11
Huvitz Co., Ltd.20
Konan Medical, Inc.20
Nidek Co., Ltd.20
Decided510(k)Device and applicantCode
Jul 17, 2026K260694ZEISS CLINIC 360
Carl Zeiss Meditec, AG, DE
NFJ
Jun 4, 2026K253893Harmony Referral System with Harmony OCT Viewer (Octave)
Topcon Healthcare Solutions EMEA Oy, FI
NFJ
Aug 22, 2024K234076iCare ALTIUS CW
Centervue S.P.A., IT
NFJ
Mar 1, 2024K232828IMAGEnet6 Ophthalmic Data System
Topcon Corporation, JP
NFJ
Dec 21, 2023K232944CALLISTO eye
Carl Zeiss Meditec, AG
NFJ
Nov 20, 2023K232555Harmony
Topcon Healthcare Solutions
NFJ
Aug 28, 2023K231676CALLISTO eye
Carl Zeiss Meditec, AG, DE
NFJ
Jul 31, 2023K232088Altris IMS
Altris, Inc.
NFJ
Oct 31, 2022K220929Excelsior
Merit Cro, Inc.
NFJ
Aug 15, 2022K213527FORUM
Carl Zeiss Meditec, AG, DE
NFJ
Apr 28, 2022K211715RetinAI Discovery
Retinai Medical AG, CH
NFJ
Sep 13, 2021K210396Harmony Referral System
Topcon Healthcare Solutions EMEA Oy, FI
NFJ
Jun 15, 2021K203244CellChek 20 rc
Konan Medical, Inc., JP
NFJ
Dec 24, 2020K200422Image Quality Analyzer (IQA)
Visionquest Biomedical, Inc.
NFJ
Sep 25, 2020K201273ImageSPECTRUM
Canon, Inc., JP
NFJ
Aug 3, 2020K200954Glaucoma Module
Topcon Healthcare Solutions, Inc.
NFJ
Mar 16, 2020K200385CONTINUUM PACS
Integrated Ophthalmic Systems, Inc.
NFJ
Mar 3, 2020K200275OVision Imaging System
Ophthalmic Labs, Inc.
NFJ
Jul 18, 2019K191615Huvitz Imaging System
Huvitz Co., Ltd., KR
NFJ
Feb 12, 2019K190056KOWA VK-2s
Kowa Co. Ltd. Chofu, JP
NFJ
Nov 2, 2018K181501Afina
Neurovision Imaging, LLC
NFJ
Oct 24, 2018K182318Retina Workplace
Carl Zeiss Meditec, Inc.
NFJ
Sep 28, 2018K182376Harmony
Topcon Medical Systems, Inc.
NFJ
Jul 19, 2018K181345Image Filing Software NAVIS-EX
Nidek Co., Ltd., JP
NFJ
Jul 16, 2018K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Welch Allyn, Inc.
NFJ
Jun 27, 2018K180858CALLISTO eye
Carl Zeiss Meditec, AG, DE
NFJ
Feb 23, 2018K173689Ophthalmic Software Platform RX
Canon Inc. -Medical Equipment Group, JP
NFJ
Nov 1, 2017K171370IMAGEnet 6 Ophthalmic Data System
Topcon Corporation, JP
NFJ
Jun 21, 2017K170638Retina Workplace
Carl Zeiss Meditec, AG, DE
NFJ
May 2, 2017K171098AXIS Image Management System
Sonomed, Inc.
NFJ
Apr 6, 2017K161829Huvitz Imaging System
Huvitz Co., Ltd., KR
NFJ
Feb 8, 2017K162039OptosAdvance 4.0 Software
Optos Plc., GB
NFJ
Oct 1, 2015K151952Synergy ODM
Topcon Medical Systems, Inc.
NFJ
May 21, 2015K150467Retina Workplace
Carl Zeiss Meditec, AG, DE
NFJ
Feb 27, 2015K141922IRIS INTELLIGENT RETINAL IMAGING SYSTEM
Intelligent Retinal Imaging Systems, LLC
NFJ
Oct 3, 2014K141297FORUM GLAUCOMA WORKPLACE
Carl Zeiss Meditec, AG
NFJ
Sep 10, 2014K142423EyeSuite Imaging
Haag-Streit AG, CH
NFJ
Oct 17, 2013K132438IMAGENET 5 PC SOFTWARE SYSTEM
Topcon Medical Systems, Inc.
NFJ
Oct 9, 2013K132667SYNERGY ODM
Topcon Medical Systems, Inc.
NFJ
Jul 23, 2013K130648FORUM GLAUCOMA WORKPLACE
Carl Zeiss Meditec, AG
NFJ
Apr 2, 2013K130453EXCELSIOR
Eyekor, LLC
NFJ
Mar 5, 2013K123464CALLISTO EYE
Carl Zeiss Meditec, AG
NFJ
Nov 2, 2012K122938FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
Carl Zeiss Meditec, AG
NFJ
May 25, 2012K113696OPTOS ADVANCE
Optos Plc.
NFJ
Jul 14, 2011K110869CARA
Diagnos, Inc.
NFJ
May 18, 2011K110006OIS SYMPHONY IMAGE MANAGMENT SYSTEM
Ophthalmic Imaging Systems
NFJ
Dec 2, 2009K093313SYNERGY
Topcon Medical Systems, Inc.
NFJ
May 6, 2009K090266MATCHEDFLICKER
Eyeic Corporation
NFJ
Mar 25, 2009K090439FORUM
Carl Zeiss Meditec, Inc.
NFJ
Jan 22, 2009K081797IMAGE STORAGE SYSTEM, MODEL KSS-400
Konan Medical, Inc.
NFJ

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