Atlas FDA

NFJ

53 FDA 510(k) clearances · Product code

107 daysmedian time to decision
245 days90th percentile
53clearances measured

FDA profile

Official device name
System, Image Management, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 29
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ZEISS CLINIC 360 (K260694)Carl Zeiss Meditec, AG2026-07-17
Harmony Referral System with Harmony OCT Viewer (Octave) (K253893)Topcon Healthcare Solutions EMEA Oy2026-06-04
iCare ALTIUS CW (K234076)Centervue S.P.A.2024-08-22
IMAGEnet6 Ophthalmic Data System (K232828)Topcon Corporation2024-03-01
CALLISTO eye (K232944)Carl Zeiss Meditec, AG2023-12-21
Harmony (K232555)Topcon Healthcare Solutions2023-11-20
CALLISTO eye (K231676)Carl Zeiss Meditec, AG2023-08-28
Altris IMS (K232088)Altris, Inc.2023-07-31
Excelsior (K220929)Merit Cro, Inc.2022-10-31
FORUM (K213527)Carl Zeiss Meditec, AG2022-08-15
RetinAI Discovery (K211715)Retinai Medical AG2022-04-28
Harmony Referral System (K210396)Topcon Healthcare Solutions EMEA Oy2021-09-13
CellChek 20 rc (K203244)Konan Medical, Inc.2021-06-15
Image Quality Analyzer (IQA) (K200422)Visionquest Biomedical, Inc.2020-12-24
ImageSPECTRUM (K201273)Canon, Inc.2020-09-25
Glaucoma Module (K200954)Topcon Healthcare Solutions, Inc.2020-08-03
CONTINUUM PACS (K200385)Integrated Ophthalmic Systems, Inc.2020-03-16
OVision Imaging System (K200275)Ophthalmic Labs, Inc.2020-03-03
Huvitz Imaging System (K191615)Huvitz Co., Ltd.2019-07-18
KOWA VK-2s (K190056)Kowa Co. Ltd. Chofu2019-02-12
Afina (K181501)Neurovision Imaging, LLC2018-11-02
Retina Workplace (K182318)Carl Zeiss Meditec, Inc.2018-10-24
Harmony (K182376)Topcon Medical Systems, Inc.2018-09-28
Image Filing Software NAVIS-EX (K181345)Nidek Co., Ltd.2018-07-19
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (K181016)Welch Allyn, Inc.2018-07-16
CALLISTO eye (K180858)Carl Zeiss Meditec, AG2018-06-27
Ophthalmic Software Platform RX (K173689)Canon Inc. -Medical Equipment Group2018-02-23
IMAGEnet 6 Ophthalmic Data System (K171370)Topcon Corporation2017-11-01
Retina Workplace (K170638)Carl Zeiss Meditec, AG2017-06-21
AXIS Image Management System (K171098)Sonomed, Inc.2017-05-02
Huvitz Imaging System (K161829)Huvitz Co., Ltd.2017-04-06
OptosAdvance 4.0 Software (K162039)Optos Plc.2017-02-08
Synergy ODM (K151952)Topcon Medical Systems, Inc.2015-10-01
Retina Workplace (K150467)Carl Zeiss Meditec, AG2015-05-21
IRIS INTELLIGENT RETINAL IMAGING SYSTEM (K141922)Intelligent Retinal Imaging Systems, LLC2015-02-27
FORUM GLAUCOMA WORKPLACE (K141297)Carl Zeiss Meditec, AG2014-10-03
EyeSuite Imaging (K142423)Haag-Streit AG2014-09-10
IMAGENET 5 PC SOFTWARE SYSTEM (K132438)Topcon Medical Systems, Inc.2013-10-17
SYNERGY ODM (K132667)Topcon Medical Systems, Inc.2013-10-09
FORUM GLAUCOMA WORKPLACE (K130648)Carl Zeiss Meditec, AG2013-07-23
EXCELSIOR (K130453)Eyekor, LLC2013-04-02
CALLISTO EYE (K123464)Carl Zeiss Meditec, AG2013-03-05
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH (K122938)Carl Zeiss Meditec, AG2012-11-02
OPTOS ADVANCE (K113696)Optos Plc.2012-05-25
CARA (K110869)Diagnos, Inc.2011-07-14
OIS SYMPHONY IMAGE MANAGMENT SYSTEM (K110006)Ophthalmic Imaging Systems2011-05-18
SYNERGY (K093313)Topcon Medical Systems, Inc.2009-12-02
MATCHEDFLICKER (K090266)Eyeic Corporation2009-05-06
FORUM (K090439)Carl Zeiss Meditec, Inc.2009-03-25
IMAGE STORAGE SYSTEM, MODEL KSS-400 (K081797)Konan Medical, Inc.2009-01-22
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR (K082364)Topcon Corp.2008-09-30
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP (K071299)Digital Healthcare, Ltd.2007-08-31
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) (K013694)Nidek, Inc.2002-11-19

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