510(k) Report

Devices descending from K973767

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+6K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+6K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+6K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+6K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+6K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+6K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.20068383
+6K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005194—
+7K251417ReVISION 2Argus Cognitive, Inc.20260—
+7K260192DIANAROPCA ApS20260—
+7K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+7K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+7K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+7K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+7K250670EchoConfidence (USA)Mycardium AI Limited20250—
+7K243937Accuro 3SRivanna Medical, Inc.20252—
+7K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K242359Strain AI (SAI001)Exo, Inc.20240—
+7K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+7K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232501AI Platform (AIP001)Exo, Inc.20231—
+7K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+7K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+7K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+7K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+7K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K212376Caas QardiaPie Medical Imaging BV20220—
+7K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+7K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+7K213275EchoGo Core (2.0)Ultromics Limited20211—
+7K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+7K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+7K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+7K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+7K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K200603AAA ModelPhilips Ultrasound, Inc.20200—
+7K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200655FibroScan® 630Echosens20200—
+7K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+7K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+7K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+7K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+7K193518KosmosEchoNous, Inc.20201—
+7K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+7K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+7K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+7K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+7K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+7K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+7K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+7K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+7K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+7K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+7K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+7K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+7K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+7K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+7K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+7K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+7K170521Trinity/3D Prostate SuiteKoelis20170—
+7K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+7K163443Interson USB Ultrasound SystemInterson Corporation20173—
+7K170445Logiq S8GE Healthcare2017191