510(k) Report

Devices descending from K033196

990 later devices reach Sonoline Antares with Clarify VE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+8K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+8K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+8K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+8K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+8K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+8K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+8K201693DC-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—
+8K2013523D Auto LAAPhilips Health Care20200—
+8K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+8K201597Liver Incytes, Model 1005Sonic Incytes20204—
+8K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+8K200356Medo AriaMedo.Ai20203—
+8K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+8K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K191171EchoGo CoreUltromics, Ltd.20193—
+8K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+8K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+8K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+8K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+8K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+8K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+8K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+8K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+8K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+8K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+8K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+8K173555Logiq E10GE Healthcare2017382
+8K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+8K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+8K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+8K171594AccuroRivanna Medical, LLC20173—
+8K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+8K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+8K172142FibroScan 430 Mini+Echosens20170—
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+8K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+8K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+8K170521Trinity/3D Prostate SuiteKoelis20170—
+8K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+8K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+8K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+8K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+8K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+8K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+8K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+8K143601U-LiteSonoscanner Sarl20153—
+8K141768Logiq V5/Logiq V3GE Healthcare201457—
+8K141675Voluson P6, Voluson P8GE Healthcare201414—
+8K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+8K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+8K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+8K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+8K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+8K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+8K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+8K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+8K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+9K251417ReVISION 2Argus Cognitive, Inc.20260—
+9K260192DIANAROPCA ApS20260—
+9K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+9K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+9K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+9K252332FolliscanMim Fertility20260—
+9K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+9K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+9K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K243937Accuro 3SRivanna Medical, Inc.20252—
+9K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+9K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—