510(k) Report

Devices descending from K973767

1,087 later devices reach Harmonic Imaging with Contrast through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192372ASCEND Image ViewerAscend Hit20200—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+5K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K181574UscanEchoNous, Inc.20180—
+5K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K161999AixplorerSupersonic Imagine201620—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+5K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+5K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+5K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+5K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+5K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+5K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+5K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+5K131527Logiq S8GE Healthcare2013219—
+5K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+5K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+5K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+5K120282CardnavPaieon, Inc.20120—
+5K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+5K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+5K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+5K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+5K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+5K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+5K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+5K120741Voluson S6, Voluson S8GE Healthcare2012295—
+5K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+5K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+5K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+5K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+5K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+5K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+5K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+5K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+5K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+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—
+6K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+6K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+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—
+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—