510(k) Report

Devices descending from K040546

184 later devices reach Image-Arena and Research-Arena Applications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103761Visualize: VascularThe Medipattern Corporation20110—
+1K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+1K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+1K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+1K041581Compacs, Version 1.0Intelligent Images Srl20041—
+2K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+2K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+2K120514CardiopacsLumedx20120—
+2K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+2K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+2K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+2K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+2K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+3K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+3K192372ASCEND Image ViewerAscend Hit20200—
+3K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+3K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+3K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K120282CardnavPaieon, Inc.20120—
+3K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+3K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+3K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+4K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+4K222406Clarius AIClarius Mobile Health Corp.20233—
+4K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+4K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+4K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+4K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+4K191171EchoGo CoreUltromics, Ltd.20193—
+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
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+4K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+5K251417ReVISION 2Argus Cognitive, Inc.20260—
+5K260192DIANAROPCA ApS20260—
+5K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+5K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+5K250670EchoConfidence (USA)Mycardium AI Limited20250—
+5K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+5K242359Strain AI (SAI001)Exo, Inc.20240—
+5K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+5K232501AI Platform (AIP001)Exo, Inc.20231—
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+5K212376Caas QardiaPie Medical Imaging BV20220—
+5K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+5K213275EchoGo Core (2.0)Ultromics Limited20211—
+5K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+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
+5K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+5K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+5K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+5K170069AmCAD-UVAmcad Biomed Corporation20170—
+5K131158CorviewMarrek, Inc.20130—
+6K2503303mensio WorkstationPie Medical Imaging BV202501
+6K252007BlineSlideDeep Breathe, Inc.20250—
+6K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+6K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, 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—
+6K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K200708Vivid iqGe Medical Systems Ultrasound And20203—
+6K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+6K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+6K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+6K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+6K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+6K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+6K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+7K260748ES-SeriesE-Scopics20260—
+7K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+7K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+7K250120GECHONarnar, LLC20250—
+7K243684BrightHeart View ClassifierBrightheart20251—
+7K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+7K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+7K240645Sonix HealthOntact Health Co., Ltd.20240—
+7K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—