510(k) Report

Devices descending from K945072

1,034 later devices reach Siemens Q4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+6K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+6K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+6K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+6K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+6K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+6K132171AixplorerSupersonic Imagine201364—
+6K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+6K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+6K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+6K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+6K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+6K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+6K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+6K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+6K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+6K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+6K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+6K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+6K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+6K121329AixplorerSupersonic Imagine2012405—
+6K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+6K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+6K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+6K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+6K111582Logiq S8GE Healthcare20113673
+6K110943Logiq E9GE Healthcare20114722
+6K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+6K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+6K103649Voluson S6, Voluson S8GE Healthcare2011296—
+6K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+6K102041AixplorerSupersonic Imagine2010527—
+6K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+6K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+6K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+6K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+6K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+6K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+6K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+6K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+6K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+6K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+6K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+6K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+6K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+6K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+6K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+6K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+6K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+6K070526DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007117—
+6K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006193—
+7K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+7K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+7K243937Accuro 3SRivanna Medical, Inc.20252—
+7K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+7K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+7K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+7K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+7K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+7K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+7K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+7K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+7K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+7K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+7K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+7K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+7K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+7K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200655FibroScan® 630Echosens20200—
+7K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+7K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K193518KosmosEchoNous, Inc.20201—
+7K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+7K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+7K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+7K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+7K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+7K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+7K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+7K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+7K173569Ultrasound System 1300Bk Medical Aps20181—
+7K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—