510(k) Report

Devices descending from K934915

1,096 later devices reach Acuson Model 2001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+5K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+5K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+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—
+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—
+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—
+6K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+6K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+6K192372ASCEND Image ViewerAscend Hit20200—
+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—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K161999AixplorerSupersonic Imagine201620—
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+6K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+6K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+6K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+6K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+6K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+6K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+6K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+6K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+6K120282CardnavPaieon, Inc.20120—
+6K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+6K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+6K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+6K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+6K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+6K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+6K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+6K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.200999—
+6K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+6K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+6K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+6K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2008278—
+6K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+6K072676Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc.20072795
+6K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+6K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20072333
+6K070515A-View Basic and PlusCordatec N.V.20071—
+6K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2007427—
+6K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+6K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+6K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+6K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+6K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+6K060879Model EC9-4 TransducerSiemens Medical Solutions USA, Inc.20061—
+6K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+6K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+6K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005972—
+6K051500Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C2005195—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+7K222406Clarius AIClarius Mobile Health Corp.20233—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+7K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+7K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+7K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+7K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+7K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K191171EchoGo CoreUltromics, Ltd.20193—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K170841BiopSee, Mobile USMedcom GmbH20170—
+7K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+7K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+7K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+7K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—