510(k) Report

Devices descending from K935595

1,088 later devices reach Acuson Model 3001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+5K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+5K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+5K111582Logiq S8GE Healthcare20113673
+5K110943Logiq E9GE Healthcare20114722
+5K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+5K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+5K103649Voluson S6, Voluson S8GE Healthcare2011296—
+5K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+5K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+5K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+5K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+5K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+5K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+5K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+5K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+5K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+5K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+5K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+5K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+5K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+5K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.200999—
+5K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+5K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+5K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+5K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2008278—
+5K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+5K072676Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc.20072795
+5K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+5K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20072333
+5K070515A-View Basic and PlusCordatec N.V.20071—
+5K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2007427—
+5K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+5K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+5K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+5K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+5K060879Model EC9-4 TransducerSiemens Medical Solutions USA, Inc.20061—
+5K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+5K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005972—
+5K051500Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C2005195—
+6K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+6K222406Clarius AIClarius Mobile Health Corp.20233—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+6K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+6K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+6K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+6K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+6K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+6K191171EchoGo CoreUltromics, Ltd.20193—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+6K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K181574UscanEchoNous, Inc.20180—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+6K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+6K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+6K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+6K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+6K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+6K170338A-ViewStroke2prevent B.V.20170—
+6K170069AmCAD-UVAmcad Biomed Corporation20170—
+6K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+6K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+6K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+6K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+6K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+6K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+6K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+6K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+6K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+6K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+6K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+6K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—