510(k) Report

Devices descending from K032111

955 later devices reach Acuson CV70 Cardiovascular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+10K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+10K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+10K234141AISAP Cardio V1.0Aisap20240—
+10K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+10K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+10K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+10K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+10K233734Interson USB Ultrasound SystemInterson Corporation20230—
+10K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+10K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+10K231764Ultrasound System 1300Bk Medical Aps202301
+10K230209Sonix HealthOntact Health Co., Ltd.20233—
+10K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+10K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+10K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+10K222441Ultrasound System 2300Bk Medical Aps20221—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+10K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+10K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+10K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+10K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K212012Follicle ClarityCycle Clarity20221—
+10K213102ES1 SystemE-Scopics20223—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+10K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+10K212035FibroScan 230Echosens20215—
+10K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+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—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+10K200708Vivid iqGe Medical Systems Ultrasound And20203—
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K2013523D Auto LAAPhilips Health Care20200—
+10K201597Liver Incytes, Model 1005Sonic Incytes20204—
+10K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+10K200356Medo AriaMedo.Ai20203—
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+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—
+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—
+10K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+10K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+10K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+10K181574UscanEchoNous, Inc.20180—
+10K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+10K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+10K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+10K173555Logiq E10GE Healthcare2017382
+10K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+10K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+10K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+10K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+10K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+10K172142FibroScan 430 Mini+Echosens20170—
+10K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+10K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K170521Trinity/3D Prostate SuiteKoelis20170—
+10K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+10K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+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—