510(k) Report

Devices descending from K061368

90 later devices reach Diagnosoft Harp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100352Diagnosoft Harp Model 2.06Diagnosoft, Inc.201089—
+2K182756MyoStrain 5.1Myocardial Solutions20191—
+2K163076Segment CMRMedviso AB20172—
+2K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+2K111833VirtueDiagnosoft, Inc.20114—
+3K241607MyoStrain (6.0)Myocardial Solutions, Inc.20240—
+3K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+3K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+3K211611QIR SuiteCasis Cardiac Simulation & Imaging Software20220—
+3K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+3K131158CorviewMarrek, Inc.20130—
+4K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+4K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+4K192372ASCEND Image ViewerAscend Hit20200—
+4K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+5K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+5K222406Clarius AIClarius Mobile Health Corp.20233—
+5K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+5K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+5K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+5K191171EchoGo CoreUltromics, Ltd.20193—
+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
+6K251417ReVISION 2Argus Cognitive, Inc.20260—
+6K260192DIANAROPCA ApS20260—
+6K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+6K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+6K250670EchoConfidence (USA)Mycardium AI Limited20250—
+6K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+6K242359Strain AI (SAI001)Exo, Inc.20240—
+6K232501AI Platform (AIP001)Exo, Inc.20231—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+6K212376Caas QardiaPie Medical Imaging BV20220—
+6K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+6K213275EchoGo Core (2.0)Ultromics Limited20211—
+6K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+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
+7K2503303mensio WorkstationPie Medical Imaging BV202501
+7K252007BlineSlideDeep Breathe, Inc.20250—
+7K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+7K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+7K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+7K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+7K234141AISAP Cardio V1.0Aisap20240—
+7K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+7K230209Sonix HealthOntact Health Co., Ltd.20233—
+7K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+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—
+8K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+8K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K243684BrightHeart View ClassifierBrightheart20251—
+8K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K240645Sonix HealthOntact Health Co., Ltd.20240—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+8K201768Voluson E10GE Healthcare20204—
+8K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K251456BrightHeart View ClassifierBrightheart20250—
+9K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+9K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+9K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+10K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+10K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+10K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+11K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+12K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—