510(k) Report

Devices descending from K973767

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+4K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K160420SpeqTSignostics Limited20161—
+4K152250SpeqRTSignostics Limited20150—
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+4K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+4K140254EZONO 4000Ezono AG201413—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+4K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+4K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+4K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+4K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+4K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+4K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+4K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+4K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+4K120514CardiopacsLumedx20120—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K111582Logiq S8GE Healthcare20113673
+4K110943Logiq E9GE Healthcare20114722
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K110688MylabgoldEsaote2011251
+4K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+4K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+4K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+4K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+4K103649Voluson S6, Voluson S8GE Healthcare2011296—
+4K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+4K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+4K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+4K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+4K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+4K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+4K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+4K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+4K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+4K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+4K083882MylabfiveEsaote Europe B.V.200926—
+4K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+4K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+4K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+4K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+4K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+4K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+4K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+4K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+4K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+4K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+4K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+4K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+4K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+4K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20059211
+4K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C20041961
+4K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927—
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+5K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+5K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—