510(k) Report

Devices descending from K934139

1,289 later devices reach Tomtec Echo-View through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+10K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+10K221335D²RS and D²RS 9090Stephanix20220—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K220871NautilusDornier Medtech America, Inc.20220—
+10K213102ES1 SystemE-Scopics20223—
+10K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K211527Exo IrisExo Imaging, Inc.20211—
+10K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K212035FibroScan 230Echosens20215—
+10K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+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—
+10K2116563D Echo v1.1Jointvue, LLC20210—
+10K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+10K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+10K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+10K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+10K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+10K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+10K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+10K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+10K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+10K201768Voluson E10GE Healthcare20204—
+10K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+10K201597Liver Incytes, Model 1005Sonic Incytes20204—
+10K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+10K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+10K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+10K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+10K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+10K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+10K193518KosmosEchoNous, Inc.20201—
+10K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+10K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+10K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+10K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+10K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+10K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+10K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+10K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+10K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+10K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+10K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+10K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+10K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+10K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+10K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+10K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+10K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+10K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+10K173555Logiq E10GE Healthcare2017382
+10K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+10K171594AccuroRivanna Medical, LLC20173—
+10K172142FibroScan 430 Mini+Echosens20170—
+10K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+10K170521Trinity/3D Prostate SuiteKoelis20170—
+10K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+10K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+10K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+10K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+10K161756SyncVision SystemVolcano Corporation201611
+10K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+10K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation20159—
+10K143122Volcano iFR Harvest Software (Offline)Volcano Corporation20150—
+10K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+10K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+10K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+10K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+10K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+10K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+10K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+10K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+10K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+10K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+10K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+10K111582Logiq S8GE Healthcare20113673
+10K110943Logiq E9GE Healthcare20114722
+10K103649Voluson S6, Voluson S8GE Healthcare2011296—
+10K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+10K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+11K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+11K251199Allia MoveoGE Medical Systems SCS202501
+11K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+11K252105Ligence HeartLigence Uab20250—