510(k) Report

Devices descending from K032281

209 later devices reach Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K213275EchoGo Core (2.0)Ultromics Limited20211—
+9K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+9K200603AAA ModelPhilips Ultrasound, Inc.20200—
+9K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+9K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+9K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+9K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+9K161999AixplorerSupersonic Imagine201620—
+9K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+9K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+9K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+9K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+9K133277XARIO 100Toshibamedical Systems Corporation20142—
+10K2503303mensio WorkstationPie Medical Imaging BV202501
+10K252007BlineSlideDeep Breathe, Inc.20250—
+10K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+10K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+10K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+10K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+10K234141AISAP Cardio V1.0Aisap20240—
+10K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+10K230209Sonix HealthOntact Health Co., Ltd.20233—
+10K223830Ultrasound System 2300Bk Medical Aps202306
+10K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+10K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+10K200708Vivid iqGe Medical Systems Ultrasound And20203—
+10K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+10K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+10K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+10K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+10K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+10K172256SoftVueDelphinus Medical Technologies20180—
+10K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+10K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+10K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+10K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+10K150949FibroScanEchosens201542—
+10K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+11K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+11K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+11K243684BrightHeart View ClassifierBrightheart20251—
+11K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K240645Sonix HealthOntact Health Co., Ltd.20240—
+11K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+11K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+11K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+11K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+11K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+11K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+11K201768Voluson E10GE Healthcare20204—
+11K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+11K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+11K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+11K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+11K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+11K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+11K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+11K160524FibroScan 530 CompactEchosens201641—
+12K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+12K251456BrightHeart View ClassifierBrightheart20250—
+12K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+12K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+12K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+12K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+12K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+12K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+12K201597Liver Incytes, Model 1005Sonic Incytes20204—
+12K200655FibroScan® 630Echosens20200—
+12K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+12K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+12K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+12K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+12K172142FibroScan 430 Mini+Echosens20170—
+12K170445Logiq S8GE Healthcare2017191
+13K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+13K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+13K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+13K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+13K223287VelacurSonic Incytes20233—
+13K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+13K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+13K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+13K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+14K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+14K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+14K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+14K232459VelacurSonic Incytes20232—
+14K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+14K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+15K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+15K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+15K233977VelacurSonic Incytes20241—
+15K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—