510(k) Report

Devices descending from K934139

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+5K132171AixplorerSupersonic Imagine201364—
+5K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+5K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+5K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+5K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+5K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+5K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+5K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+5K111142Echosoft (TM)Echometrix, LLC20120—
+5K121329AixplorerSupersonic Imagine2012405—
+5K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+5K120514CardiopacsLumedx20120—
+5K121384MylabsognoEsaote, S.p.A.201211
+5K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+5K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+5K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+5K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+5K110688MylabgoldEsaote2011251
+5K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+5K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+5K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+5K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+5K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+5K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+5K102041AixplorerSupersonic Imagine2010527—
+5K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc.20100—
+5K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+5K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+5K091780Guided Measurement Catheter (GMC)Mediguide, Ltd.20091—
+5K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+5K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+5K091680Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.200925—
+5K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+5K083882MylabfiveEsaote Europe B.V.200926—
+5K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+5K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+5K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+5K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+5K081873Emp-2100 Full Digital Ultrasound Diagnostic DeviceShenzhen Emperor Electronic Technology Co., Ltd.20083—
+5K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+5K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+5K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+5K073473Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter…Volcano Corporation200814—
+5K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+5K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+5K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+5K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+5K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+5K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+5K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+5K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+5K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+5K052805MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A.200560—
+5K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+5K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+5K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+5K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+5K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20059211
+5K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C20041961
+5K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927—
+6K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+6K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+6K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+6K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+6K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+6K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+6K192372ASCEND Image ViewerAscend Hit20200—
+6K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+6K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+6K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+6K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+6K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+6K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+6K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+6K170856CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20171—
+6K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—