510(k) Report

Devices descending from K032114

1,003 later devices reach Sequoia 8.0 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+1K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004988—
+1K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184—
+2K103761Visualize: VascularThe Medipattern Corporation20110—
+2K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+2K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+2K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+2K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+2K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+2K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+2K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+2K041581Compacs, Version 1.0Intelligent Images Srl20041—
+3K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+3K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+3K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+3K120514CardiopacsLumedx20120—
+3K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+3K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+3K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+3K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+3K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+3K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+3K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+3K082135ShowcaseTrillium Technology, Inc.20080—
+3K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+3K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+3K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20072333
+3K070515A-View Basic and PlusCordatec N.V.20071—
+3K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+3K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+3K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005972—
+3K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+4K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+4K192372ASCEND Image ViewerAscend Hit20200—
+4K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+4K170338A-ViewStroke2prevent B.V.20170—
+4K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+4K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+4K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+4K140153Ventripoint Medical SystemVentripoint, Inc.20142—
+4K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+4K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+4K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+4K120282CardnavPaieon, Inc.20120—
+4K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+4K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011100—
+4K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+4K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+4K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+4K083597Sonowand InviteSonowand AS20093—
+4K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+4K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+4K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+4K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+4K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+4K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+4K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+4K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.20068383
+4K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+5K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+5K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+5K222406Clarius AIClarius Mobile Health Corp.20233—
+5K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+5K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+5K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+5K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+5K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+5K191171EchoGo CoreUltromics, Ltd.20193—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+5K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K160420SpeqTSignostics Limited20161—
+5K152250SpeqRTSignostics Limited20150—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+5K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+5K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+5K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+5K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+5K130779Lvivo EF SystemDiacardio, Ltd.201324—
+5K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+5K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—