510(k) Report

Devices descending from K100352

89 later devices reach Diagnosoft Harp Model 2.06 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182756MyoStrain 5.1Myocardial Solutions20191—
+1K163076Segment CMRMedviso AB20172—
+1K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+1K111833VirtueDiagnosoft, Inc.20114—
+2K241607MyoStrain (6.0)Myocardial Solutions, Inc.20240—
+2K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+2K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+2K211611QIR SuiteCasis Cardiac Simulation & Imaging Software20220—
+2K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+2K131158CorviewMarrek, Inc.20130—
+3K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+3K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+3K192372ASCEND Image ViewerAscend Hit20200—
+3K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+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
+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—
+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
+6K2503303mensio WorkstationPie Medical Imaging BV202501
+6K252007BlineSlideDeep Breathe, Inc.20250—
+6K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+6K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+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—
+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
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+7K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+7K243684BrightHeart View ClassifierBrightheart20251—
+7K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+7K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+7K240645Sonix HealthOntact Health Co., Ltd.20240—
+7K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+7K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+7K201768Voluson E10GE Healthcare20204—
+7K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+7K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+8K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+8K251456BrightHeart View ClassifierBrightheart20250—
+8K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+8K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+8K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+8K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+9K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+9K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+9K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+10K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+11K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—