510(k) Report

Devices descending from K072090

189 later devices reach Siemens Diagnostic Ultrasound Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+1K130779Lvivo EF SystemDiacardio, Ltd.201324—
+1K120282CardnavPaieon, Inc.20120—
+1K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+1K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+2K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+2K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+2K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+2K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+2K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+2K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+2K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+2K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+3K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+3K220956Libby Echo:PrioDyad Medical, Inc.20221—
+3K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+3K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+3K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+3K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+3K193518KosmosEchoNous, Inc.20201—
+3K192372ASCEND Image ViewerAscend Hit20200—
+3K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+3K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+3K131158CorviewMarrek, Inc.20130—
+3K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+4K252105Ligence HeartLigence Uab20250—
+4K250670EchoConfidence (USA)Mycardium AI Limited20250—
+4K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+4K241430EchoMeasureIcardio.Ai20240—
+4K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+4K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+4K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+4K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+4K222406Clarius AIClarius Mobile Health Corp.20233—
+4K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+4K212100KosmosEchoNous, Inc.202101
+4K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+4K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+4K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+4K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+4K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+4K191171EchoGo CoreUltromics, Ltd.20193—
+4K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+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
+4K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+4K170069AmCAD-UVAmcad Biomed Corporation20170—
+5K251417ReVISION 2Argus Cognitive, Inc.20260—
+5K260192DIANAROPCA ApS20260—
+5K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+5K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+5K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+5K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+5K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K242359Strain AI (SAI001)Exo, Inc.20240—
+5K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+5K232501AI Platform (AIP001)Exo, Inc.20231—
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+5K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K212376Caas QardiaPie Medical Imaging BV20220—
+5K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+5K213275EchoGo Core (2.0)Ultromics Limited20211—
+5K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+5K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K200603AAA ModelPhilips Ultrasound, Inc.20200—
+5K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+5K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+5K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+5K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+5K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+5K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+5K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+5K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+5K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+5K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+6K260748ES-SeriesE-Scopics20260—
+6K2503303mensio WorkstationPie Medical Imaging BV202501
+6K252007BlineSlideDeep Breathe, Inc.20250—
+6K250120GECHONarnar, LLC20250—
+6K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+6K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+6K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+6K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+6K234141AISAP Cardio V1.0Aisap20240—
+6K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+6K230209Sonix HealthOntact Health Co., Ltd.20233—
+6K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+6K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+6K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171