510(k) Report

Devices descending from K946179

931 later devices reach Siemens Sonoline 4XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+11K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+11K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+11K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+11K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+11K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+11K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+11K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+11K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+11K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+11K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+11K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+11K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+11K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+11K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+11K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+11K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+11K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+11K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+11K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+11K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+11K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+11K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+11K181574UscanEchoNous, Inc.20180—
+11K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+11K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+11K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+11K173555Logiq E10GE Healthcare2017382
+11K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+11K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+11K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+11K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+11K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+11K172142FibroScan 430 Mini+Echosens20170—
+11K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+11K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K170521Trinity/3D Prostate SuiteKoelis20170—
+11K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+11K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+11K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+11K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+11K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+11K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+11K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+11K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+11K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+11K143601U-LiteSonoscanner Sarl20153—
+11K141768Logiq V5/Logiq V3GE Healthcare201457—
+11K141675Voluson P6, Voluson P8GE Healthcare201414—
+11K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+11K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+11K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+11K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+12K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+12K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+12K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+12K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+12K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+12K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+12K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+12K243684BrightHeart View ClassifierBrightheart20251—
+12K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+12K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+12K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+12K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+12K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+12K240645Sonix HealthOntact Health Co., Ltd.20240—
+12K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+12K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+12K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+12K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+12K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+12K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+12K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+12K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+12K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+12K232336ES Series V2E-Scopics20232—
+12K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K223287VelacurSonic Incytes20233—
+12K223830Ultrasound System 2300Bk Medical Aps202306
+12K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+12K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+12K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+12K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+12K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+12K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+12K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+12K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—