510(k) Report

Devices descending from K042770

932 later devices reach Modification to Acuson CV70 Cardiovascular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+10K212035FibroScan 230Echosens20215—
+10K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+10K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+10K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+10K200603AAA ModelPhilips Ultrasound, Inc.20200—
+10K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K201597Liver Incytes, Model 1005Sonic Incytes20204—
+10K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+10K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+10K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+10K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+10K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+10K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+10K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+10K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+10K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+10K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+10K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+10K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+10K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+10K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+10K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+10K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+10K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+10K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+10K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+10K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+10K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+10K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+10K181574UscanEchoNous, Inc.20180—
+10K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+10K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+10K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+10K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+10K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+10K173555Logiq E10GE Healthcare2017382
+10K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+10K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+10K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+10K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+10K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+10K172142FibroScan 430 Mini+Echosens20170—
+10K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+10K170521Trinity/3D Prostate SuiteKoelis20170—
+10K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+10K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+10K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+10K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+10K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+10K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+10K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+10K143601U-LiteSonoscanner Sarl20153—
+10K141768Logiq V5/Logiq V3GE Healthcare201457—
+10K141675Voluson P6, Voluson P8GE Healthcare201414—
+10K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+10K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+10K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+10K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+11K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K2503303mensio WorkstationPie Medical Imaging BV202501
+11K252007BlineSlideDeep Breathe, Inc.20250—
+11K250120GECHONarnar, LLC20250—
+11K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+11K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+11K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+11K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+11K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+11K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+11K234141AISAP Cardio V1.0Aisap20240—
+11K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+11K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+11K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+11K230209Sonix HealthOntact Health Co., Ltd.20233—
+11K232336ES Series V2E-Scopics20232—
+11K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+11K223287VelacurSonic Incytes20233—
+11K223830Ultrasound System 2300Bk Medical Aps202306
+11K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+11K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+11K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—