510(k) Report

Devices descending from K050034

921 later devices reach Sonoline Antares Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+7K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+7K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+7K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+7K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+7K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+7K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+7K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+7K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+7K222406Clarius AIClarius Mobile Health Corp.20233—
+7K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+7K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+7K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+7K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+7K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+7K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+7K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+7K212100KosmosEchoNous, Inc.202101
+7K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+7K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+7K2116563D Echo v1.1Jointvue, LLC20210—
+7K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+7K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+7K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+7K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+7K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+7K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+7K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+7K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+7K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+7K200655FibroScan® 630Echosens20200—
+7K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+7K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+7K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+7K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+7K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+7K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+7K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+7K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+7K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+7K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+7K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+7K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+7K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+7K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+7K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+7K191171EchoGo CoreUltromics, Ltd.20193—
+7K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+7K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+7K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+7K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+7K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+7K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+7K173569Ultrasound System 1300Bk Medical Aps20181—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+7K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+7K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+7K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+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
+7K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+7K163443Interson USB Ultrasound SystemInterson Corporation20173—
+7K170445Logiq S8GE Healthcare2017191
+7K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+7K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+7K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+7K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+7K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+7K162549Lumify Ultrasound SystemPhilips Health Care2016436
+7K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+7K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K160357TrinityKoelis20161—
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+7K160420SpeqTSignostics Limited20161—
+7K160524FibroScan 530 CompactEchosens201641—
+7K160182LOGIQ S7 ExpertGE Healthcare2016361