510(k) Report

Devices descending from K033650

945 later devices reach Acunav 90/10 Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K133533Logiq EGE Healthcare2014149—
+11K133034Logiq F SeriesGE Healthcare2014155—
+11K133431VENUE 50GE Healthcare201360—
+11K131937Voluson I/EGE Healthcare201335—
+11K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+11K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+11K1311184D VIEWGE Healthcare20131—
+11K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+11K122387Voluson P6, Voluson P8GE Healthcare2012201—
+11K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+12K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+12K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+12K2503303mensio WorkstationPie Medical Imaging BV202501
+12K252007BlineSlideDeep Breathe, Inc.20250—
+12K250120GECHONarnar, LLC20250—
+12K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+12K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+12K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+12K234141AISAP Cardio V1.0Aisap20240—
+12K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+12K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+12K233734Interson USB Ultrasound SystemInterson Corporation20230—
+12K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+12K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+12K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K230209Sonix HealthOntact Health Co., Ltd.20233—
+12K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+12K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+12K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+12K222441Ultrasound System 2300Bk Medical Aps20221—
+12K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+12K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+12K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K213102ES1 SystemE-Scopics20223—
+12K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+12K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+12K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+12K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+12K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+12K212035FibroScan 230Echosens20215—
+12K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+12K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+12K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+12K200708Vivid iqGe Medical Systems Ultrasound And20203—
+12K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+12K201597Liver Incytes, Model 1005Sonic Incytes20204—
+12K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+12K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+12K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+12K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+12K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+12K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+12K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+12K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+12K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+12K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+12K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+12K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+12K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+12K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+12K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+12K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+12K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+12K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+12K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+12K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+12K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+12K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+12K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+12K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+12K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+12K181574UscanEchoNous, Inc.20180—
+12K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+12K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+12K173555Logiq E10GE Healthcare2017382
+12K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+12K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+12K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+12K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+12K172142FibroScan 430 Mini+Echosens20170—
+12K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+12K170521Trinity/3D Prostate SuiteKoelis20170—
+12K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+12K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+12K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+12K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+12K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+12K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+12K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+12K143601U-LiteSonoscanner Sarl20153—