510(k) Report

Devices descending from K042593

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K232501AI Platform (AIP001)Exo, Inc.20231—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+10K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+10K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+10K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+10K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+10K212376Caas QardiaPie Medical Imaging BV20220—
+10K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+10K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+10K213275EchoGo Core (2.0)Ultromics Limited20211—
+10K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+10K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+10K2116563D Echo v1.1Jointvue, LLC20210—
+10K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+10K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+10K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+10K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+10K200603AAA ModelPhilips Ultrasound, Inc.20200—
+10K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+10K200655FibroScan® 630Echosens20200—
+10K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+10K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+10K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+10K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+10K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+10K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+10K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+10K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+10K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+10K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+10K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+10K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+10K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+10K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+10K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+10K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+10K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+10K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+10K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+10K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+10K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+10K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+10K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+10K173569Ultrasound System 1300Bk Medical Aps20181—
+10K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+10K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+10K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+10K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+10K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+10K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+10K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+10K163443Interson USB Ultrasound SystemInterson Corporation20173—
+10K170445Logiq S8GE Healthcare2017191
+10K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+10K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+10K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+10K162549Lumify Ultrasound SystemPhilips Health Care2016436
+10K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+10K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+10K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+10K160357TrinityKoelis20161—
+10K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+10K160420SpeqTSignostics Limited20161—
+10K160524FibroScan 530 CompactEchosens201641—
+10K160182LOGIQ S7 ExpertGE Healthcare2016361
+10K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+10K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+10K143452Logiq P9, Logiq P7GE Healthcare2015131—
+10K141639Voluson S6, Voluson S8GE Healthcare2014151—
+10K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+10K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+10K133533Logiq EGE Healthcare2014149—
+10K133034Logiq F SeriesGE Healthcare2014155—
+10K133431VENUE 50GE Healthcare201360—
+10K131937Voluson I/EGE Healthcare201335—
+10K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+10K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+10K1311184D VIEWGE Healthcare20131—
+10K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+10K122387Voluson P6, Voluson P8GE Healthcare2012201—
+10K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+11K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+11K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—