510(k) Report

Devices descending from K003125

951 later devices reach Sonoline Elegra Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+10K212376Caas QardiaPie Medical Imaging BV20220—
+10K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K212012Follicle ClarityCycle Clarity20221—
+10K213102ES1 SystemE-Scopics20223—
+10K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+10K213275EchoGo Core (2.0)Ultromics Limited20211—
+10K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+10K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+10K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+10K212035FibroScan 230Echosens20215—
+10K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+10K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+10K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K200603AAA ModelPhilips Ultrasound, Inc.20200—
+10K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K2013523D Auto LAAPhilips Health Care20200—
+10K201597Liver Incytes, Model 1005Sonic Incytes20204—
+10K200356Medo AriaMedo.Ai20203—
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+10K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+10K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+10K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+10K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+10K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+10K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+10K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+10K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+10K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+10K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+10K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+10K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+10K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+10K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+10K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+10K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+10K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+10K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+10K181574UscanEchoNous, Inc.20180—
+10K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+10K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+10K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+10K173555Logiq E10GE Healthcare2017382
+10K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+10K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+10K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+10K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+10K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+10K172142FibroScan 430 Mini+Echosens20170—
+10K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+10K170521Trinity/3D Prostate SuiteKoelis20170—
+10K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+10K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+10K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+10K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+10K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+10K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+10K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+10K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+10K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+10K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+10K143601U-LiteSonoscanner Sarl20153—
+10K141768Logiq V5/Logiq V3GE Healthcare201457—
+10K141675Voluson P6, Voluson P8GE Healthcare201414—
+10K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+10K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+10K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+10K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+11K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K252332FolliscanMim Fertility20260—
+11K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+11K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K2503303mensio WorkstationPie Medical Imaging BV202501
+11K252007BlineSlideDeep Breathe, Inc.20250—
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+11K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—