510(k) Report

Devices descending from K954668

131 later devices reach HP Echo Image Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030242FyrelinkMpacs, LLC20030—
+1K022788Philips Harmony Release 1Philips Medical Systems North America Co.20021292
+2K061995XceleraPhilips Medical Systems North America Co.2006128—
+3K153022Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV2015213
+3K140808Q-StationPhilips Ultrasound, Inc.201402
+3K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+3K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+3K103815Q-StationPhilips Ultrasound, Inc.20111—
+3K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+3K070322Syngo Dynamics, Version 6.0Siemens Medical Solutions USA, Inc.200792
+4K251215Philips IntelliSpace CardiovascularPhilips Medical Systems Nederland B.V.20250—
+4K1537363mensio WorkstationPie Medical Imaging BV2016191
+4K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+4K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+4K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+4K131385Easy-GraftDegradable Solutions AG20130—
+4K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+4K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+4K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K2503303mensio WorkstationPie Medical Imaging BV202501
+5K242500LaralabLaralab GmbH20250—
+5K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+5K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+5K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+5K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+5K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+5K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+5K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+5K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+5K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+5K192372ASCEND Image ViewerAscend Hit20200—
+5K191171EchoGo CoreUltromics, Ltd.20193—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K190874Materialise Mimics EnlightMaterialise NV20192—
+5K181080McKesson CardiologyChange Healthcare Israel, Ltd.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
+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—
+6K252195ARTICOR plannerArtiness S.R.L20260—
+6K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K250670EchoConfidence (USA)Mycardium AI Limited20250—
+6K242166TribusConnectTribusmed Beheer BV20250—
+6K233217Mimics Cardiac PlannerMaterialise NV20240—
+6K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K222406Clarius AIClarius Mobile Health Corp.20233—
+6K212376Caas QardiaPie Medical Imaging BV20220—
+6K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+6K213275EchoGo Core (2.0)Ultromics Limited20211—
+6K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.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—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+6K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+6K131158CorviewMarrek, Inc.20130—
+6K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+6K120282CardnavPaieon, Inc.20120—
+6K120514CardiopacsLumedx20120—
+7K260192DIANAROPCA ApS20260—
+7K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+7K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+7K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+7K242359Strain AI (SAI001)Exo, Inc.20240—
+7K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+7K234141AISAP Cardio V1.0Aisap20240—
+7K232501AI Platform (AIP001)Exo, Inc.20231—
+7K230209Sonix HealthOntact Health Co., Ltd.20233—
+7K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+7K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+7K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+8K252007BlineSlideDeep Breathe, Inc.20250—
+8K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K243684BrightHeart View ClassifierBrightheart20251—
+8K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+8K240645Sonix HealthOntact Health Co., Ltd.20240—
+8K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+8K240953AI Platform 2.0 (AIP002)Exo Imaging20241—