510(k) Report

Devices descending from K900889

96 later devices reach Magnetic Resonance Diagnostic Device Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973799Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSiemens Medical Solutions USA, Inc.199895—
+2K061368Diagnosoft HarpDiagnosoft, Inc.200690—
+2K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc.19992—
+2K982834Restgrid Package/Gyroscan NTPhilips Medical Systems North America, Inc.19980—
+3K100352Diagnosoft Harp Model 2.06Diagnosoft, Inc.201089—
+3K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc.20001—
+4K182756MyoStrain 5.1Myocardial Solutions20191—
+4K163076Segment CMRMedviso AB20172—
+4K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+4K111833VirtueDiagnosoft, Inc.20114—
+4K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C20020—
+5K241607MyoStrain (6.0)Myocardial Solutions, Inc.20240—
+5K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+5K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+5K211611QIR SuiteCasis Cardiac Simulation & Imaging Software20220—
+5K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+5K131158CorviewMarrek, Inc.20130—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+6K192372ASCEND Image ViewerAscend Hit20200—
+6K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+7K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+7K222406Clarius AIClarius Mobile Health Corp.20233—
+7K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+7K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+7K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+7K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+7K191171EchoGo CoreUltromics, Ltd.20193—
+7K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+7K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+7K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+8K251417ReVISION 2Argus Cognitive, Inc.20260—
+8K260192DIANAROPCA ApS20260—
+8K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+8K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+8K250670EchoConfidence (USA)Mycardium AI Limited20250—
+8K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+8K242359Strain AI (SAI001)Exo, Inc.20240—
+8K232501AI Platform (AIP001)Exo, Inc.20231—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+8K212376Caas QardiaPie Medical Imaging BV20220—
+8K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+8K213275EchoGo Core (2.0)Ultromics Limited20211—
+8K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+8K200603AAA ModelPhilips Ultrasound, Inc.20200—
+8K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+8K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+9K2503303mensio WorkstationPie Medical Imaging BV202501
+9K252007BlineSlideDeep Breathe, Inc.20250—
+9K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+9K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+9K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+9K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+9K234141AISAP Cardio V1.0Aisap20240—
+9K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+9K230209Sonix HealthOntact Health Co., Ltd.20233—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+9K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+9K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+9K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+10K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+10K243684BrightHeart View ClassifierBrightheart20251—
+10K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K240645Sonix HealthOntact Health Co., Ltd.20240—
+10K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+10K201768Voluson E10GE Healthcare20204—
+10K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+11K251456BrightHeart View ClassifierBrightheart20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+11K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+11K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+11K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+12K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+14K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—