510(k) Report

Devices descending from K040970

420 later devices reach Leonardo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K2503303mensio WorkstationPie Medical Imaging BV202501
+5K242500LaralabLaralab GmbH20250—
+5K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+5K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+5K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+5K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+5K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+5K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+5K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K202056Kinepict Medical Imaging Tool 4.0Kinepict Health, Ltd.20210—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+5K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192372ASCEND Image ViewerAscend Hit20200—
+5K191171EchoGo CoreUltromics, Ltd.20193—
+5K191544Synapse 3D Blood Flow AnalysisFujifilm Corporation20190—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K190874Materialise Mimics EnlightMaterialise NV20192—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+5K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+5K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+5K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+5K163285syngo Application SoftwareSiemens Medical Solution USA, Inc.201710—
+5K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+5K163253Arterys Cardio DLArterys, Inc.20174—
+5K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+5K122136VitreaviewVital Images, Inc.201215—
+5K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+5K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+5K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+5K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+6K251417ReVISION 2Argus Cognitive, Inc.20260—
+6K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+6K260300WatchMate SoftwareAnumana, Inc.20260—
+6K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+6K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+6K252195ARTICOR plannerArtiness S.R.L20260—
+6K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K250670EchoConfidence (USA)Mycardium AI Limited20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated20250—
+6K242166TribusConnectTribusmed Beheer BV20250—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K233217Mimics Cardiac PlannerMaterialise NV20240—
+6K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+6K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+6K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+6K223261Open RibCanon Medical Informatics, Inc.20230—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K222406Clarius AIClarius Mobile Health Corp.20233—
+6K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+6K212376Caas QardiaPie Medical Imaging BV20220—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+6K213275EchoGo Core (2.0)Ultromics Limited20211—
+6K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+6K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+6K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+6K200603AAA ModelPhilips Ultrasound, Inc.20200—
+6K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+6K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+6K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—