510(k) Report

Devices descending from K042593

930 later devices reach Acuson Acunav 8F Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K2503303mensio WorkstationPie Medical Imaging BV202501
+11K252007BlineSlideDeep Breathe, Inc.20250—
+11K250120GECHONarnar, LLC20250—
+11K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+11K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+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—
+11K233734Interson USB Ultrasound SystemInterson Corporation20230—
+11K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+11K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+11K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+11K231764Ultrasound System 1300Bk Medical Aps202301
+11K230209Sonix HealthOntact Health Co., Ltd.20233—
+11K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+11K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+11K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+11K222441Ultrasound System 2300Bk Medical Aps20221—
+11K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+11K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+11K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+11K213102ES1 SystemE-Scopics20223—
+11K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+11K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+11K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+11K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+11K212035FibroScan 230Echosens20215—
+11K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+11K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+11K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+11K200708Vivid iqGe Medical Systems Ultrasound And20203—
+11K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+11K201597Liver Incytes, Model 1005Sonic Incytes20204—
+11K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+11K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+11K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+11K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+11K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+11K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+11K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+11K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+11K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+11K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+11K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+11K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+11K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+11K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+11K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+11K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+11K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+11K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+11K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+11K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+11K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+11K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+11K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+11K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+11K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+11K181574UscanEchoNous, Inc.20180—
+11K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+11K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+11K173555Logiq E10GE Healthcare2017382
+11K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+11K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+11K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+11K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+11K172142FibroScan 430 Mini+Echosens20170—
+11K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+11K170521Trinity/3D Prostate SuiteKoelis20170—
+11K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+11K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+11K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+11K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+11K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+11K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+11K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+11K143601U-LiteSonoscanner Sarl20153—
+11K141768Logiq V5/Logiq V3GE Healthcare201457—
+11K141675Voluson P6, Voluson P8GE Healthcare201414—
+11K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+11K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+11K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+11K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+12K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+12K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+12K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+12K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+12K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+12K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+12K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+12K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I