510(k) Report

Devices descending from K042203

165 later devices reach Leonardo Syngo Cardiology Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152949WebPAXHeart Imaging Technologies, LLC20160—
+1K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+1K103565Medvoxel Heartpro Software ApplicationMedvoxel Systems, Inc.201111—
+1K061995XceleraPhilips Medical Systems North America Co.2006128—
+1K051325Webpax, Model 200Heart Imaging Technologies, LLC200523—
+2K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+2K153022Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV2015213
+2K140808Q-StationPhilips Ultrasound, Inc.201402
+2K133937Heartscan SoftwareMorpheus Imaging, Inc.201410—
+2K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+2K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+2K103815Q-StationPhilips Ultrasound, Inc.20111—
+2K092915Cedara Webaccess, Model: 2.4Cedara Software Corp.2010214
+2K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+2K070322Syngo Dynamics, Version 6.0Siemens Medical Solutions USA, Inc.200792
+3K251215Philips IntelliSpace CardiovascularPhilips Medical Systems Nederland B.V.20250—
+3K220349TeraRecon NeuroTerarecon,Inc.20220—
+3K182290IBM iConnect AccessMerge Healthcare Incorporated20183—
+3K162376CAAS MR 4D FlowPie Medical Imaging BV20163—
+3K162513Arterys Software v2.0Arterys, Inc.20165—
+3K1537363mensio WorkstationPie Medical Imaging BV2016191
+3K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+3K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+3K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+3K131385Easy-GraftDegradable Solutions AG20130—
+3K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+3K111892Vitreaview Software 6.1Vital Images, Inc.201116—
+3K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+3K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K2503303mensio WorkstationPie Medical Imaging BV202501
+4K242500LaralabLaralab GmbH20250—
+4K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+4K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+4K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+4K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+4K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+4K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+4K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+4K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+4K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+4K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+4K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+4K192372ASCEND Image ViewerAscend Hit20200—
+4K191171EchoGo CoreUltromics, Ltd.20193—
+4K191544Synapse 3D Blood Flow AnalysisFujifilm Corporation20190—
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K190874Materialise Mimics EnlightMaterialise NV20192—
+4K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+4K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+4K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+4K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+4K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+4K163253Arterys Cardio DLArterys, Inc.20174—
+4K122136VitreaviewVital Images, Inc.201215—
+4K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+4K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+4K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+4K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+5K251417ReVISION 2Argus Cognitive, Inc.20260—
+5K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+5K260300WatchMate SoftwareAnumana, Inc.20260—
+5K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+5K252195ARTICOR plannerArtiness S.R.L20260—
+5K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K250670EchoConfidence (USA)Mycardium AI Limited20250—
+5K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated20250—
+5K242166TribusConnectTribusmed Beheer BV20250—
+5K233217Mimics Cardiac PlannerMaterialise NV20240—
+5K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+5K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K222406Clarius AIClarius Mobile Health Corp.20233—
+5K212376Caas QardiaPie Medical Imaging BV20220—
+5K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+5K213275EchoGo Core (2.0)Ultromics Limited20211—
+5K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+5K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+5K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+5K200603AAA ModelPhilips Ultrasound, Inc.20200—
+5K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+5K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+5K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+5K182034Arterys MICAArterys, Inc.20183—
+5K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+5K150738VitreaViewVital Images, Inc.20158—
+5K131158CorviewMarrek, Inc.20130—
+5K121916IntuitionTerarecon,Inc.201351
+5K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+5K120282CardnavPaieon, Inc.20120—
+5K120514CardiopacsLumedx20120—
+6K260192DIANAROPCA ApS20260—
+6K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+6K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+6K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+6K242359Strain AI (SAI001)Exo, Inc.20240—