510(k) Report

Devices descending from K960043

145 later devices reach Kodak Cardiology Digital Archive & Review System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992575Cardiovascular Workstation, Model CWS 5000/CWS 3000Infimed, Inc.19990—
+1K972229Imageview Coronary Angiography Display and Review SystemHeartware, Inc.1997143—
+2K994210Inturis SuitePhilips Medical Systems, Inc.2000142—
+3K050228Agfa Heartlab CardiovascularHeartlab, Inc.2005922
+3K040896Modification to EncompassHeartlab, Inc.200411
+3K022788Philips Harmony Release 1Philips Medical Systems North America Co.20021292
+4K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+4K061995XceleraPhilips Medical Systems North America Co.2006128—
+4K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc.200572
+4K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+5K153022Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV2015213
+5K140808Q-StationPhilips Ultrasound, Inc.201402
+5K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+5K111319Ibis Explorer and Markup SoftwareMedqia20116—
+5K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+5K103815Q-StationPhilips Ultrasound, Inc.20111—
+5K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+5K070322Syngo Dynamics, Version 6.0Siemens Medical Solutions USA, Inc.200792
+6K251215Philips IntelliSpace CardiovascularPhilips Medical Systems Nederland B.V.20250—
+6K1537363mensio WorkstationPie Medical Imaging BV2016191
+6K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+6K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+6K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+6K131385Easy-GraftDegradable Solutions AG20130—
+6K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+6K122205EXINIExini Diagnostics AB20125—
+6K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+6K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K2503303mensio WorkstationPie Medical Imaging BV202501
+7K242500LaralabLaralab GmbH20250—
+7K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+7K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+7K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+7K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+7K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+7K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+7K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+7K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+7K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+7K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+7K192372ASCEND Image ViewerAscend Hit20200—
+7K191171EchoGo CoreUltromics, Ltd.20193—
+7K191262aBSIExini Diagnostics AB20192—
+7K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+7K190874Materialise Mimics EnlightMaterialise NV20192—
+7K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+7K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+7K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+7K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+7K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+7K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+7K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+7K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+7K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+8K251417ReVISION 2Argus Cognitive, Inc.20260—
+8K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+8K260300WatchMate SoftwareAnumana, Inc.20260—
+8K252195ARTICOR plannerArtiness S.R.L20260—
+8K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+8K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+8K250670EchoConfidence (USA)Mycardium AI Limited20250—
+8K242166TribusConnectTribusmed Beheer BV20250—
+8K233998TRAQinform IQAiq Global, Inc.20240—
+8K233217Mimics Cardiac PlannerMaterialise NV20240—
+8K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K222406Clarius AIClarius Mobile Health Corp.20233—
+8K212376Caas QardiaPie Medical Imaging BV20220—
+8K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+8K213275EchoGo Core (2.0)Ultromics Limited20211—
+8K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+8K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+8K200603AAA ModelPhilips Ultrasound, Inc.20200—
+8K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+8K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+8K131158CorviewMarrek, Inc.20130—
+8K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+8K120282CardnavPaieon, Inc.20120—
+8K120514CardiopacsLumedx20120—
+9K260192DIANAROPCA ApS20260—
+9K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+9K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+9K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+9K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+9K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+9K242359Strain AI (SAI001)Exo, Inc.20240—
+9K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+9K234141AISAP Cardio V1.0Aisap20240—
+9K232501AI Platform (AIP001)Exo, Inc.20231—
+9K230209Sonix HealthOntact Health Co., Ltd.20233—
+9K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—