510(k) Report

Devices descending from K982976

213 later devices reach Ultrasound Workstation, Uiws-300A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K212376Caas QardiaPie Medical Imaging BV20220—
+12K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+12K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+12K213275EchoGo Core (2.0)Ultromics Limited20211—
+12K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+12K200603AAA ModelPhilips Ultrasound, Inc.20200—
+12K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+12K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+12K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+12K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+12K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+12K161999AixplorerSupersonic Imagine201620—
+12K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+12K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+12K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+12K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+12K133277XARIO 100Toshibamedical Systems Corporation20142—
+13K2503303mensio WorkstationPie Medical Imaging BV202501
+13K252007BlineSlideDeep Breathe, Inc.20250—
+13K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+13K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+13K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+13K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+13K234141AISAP Cardio V1.0Aisap20240—
+13K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+13K230209Sonix HealthOntact Health Co., Ltd.20233—
+13K223830Ultrasound System 2300Bk Medical Aps202306
+13K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+13K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+13K200708Vivid iqGe Medical Systems Ultrasound And20203—
+13K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+13K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+13K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+13K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+13K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+13K172256SoftVueDelphinus Medical Technologies20180—
+13K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+13K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+13K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+13K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+13K150949FibroScanEchosens201542—
+13K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+14K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+14K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+14K243684BrightHeart View ClassifierBrightheart20251—
+14K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+14K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+14K240645Sonix HealthOntact Health Co., Ltd.20240—
+14K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+14K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+14K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+14K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+14K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+14K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+14K201768Voluson E10GE Healthcare20204—
+14K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+14K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+14K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+14K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+14K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+14K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+14K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+14K160524FibroScan 530 CompactEchosens201641—
+15K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+15K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+15K251456BrightHeart View ClassifierBrightheart20250—
+15K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+15K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+15K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+15K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+15K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+15K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+15K201597Liver Incytes, Model 1005Sonic Incytes20204—
+15K200655FibroScan® 630Echosens20200—
+15K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+15K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+15K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+15K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+15K172142FibroScan 430 Mini+Echosens20170—
+15K170445Logiq S8GE Healthcare2017191
+16K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+16K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+16K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+16K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+16K223287VelacurSonic Incytes20233—
+16K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+16K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+16K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+16K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+17K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+17K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+17K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+17K232459VelacurSonic Incytes20232—
+17K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+17K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+18K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—