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
+11K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+11K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+11K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+11K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+11K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+11K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+11K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+11K242359Strain AI (SAI001)Exo, Inc.20240—
+11K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+11K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+11K232501AI Platform (AIP001)Exo, Inc.20231—
+11K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+11K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+11K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+11K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+11K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+11K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+11K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+11K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+11K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+11K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+11K212376Caas QardiaPie Medical Imaging BV20220—
+11K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+11K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+11K213275EchoGo Core (2.0)Ultromics Limited20211—
+11K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+11K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+11K2116563D Echo v1.1Jointvue, LLC20210—
+11K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+11K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+11K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+11K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+11K200603AAA ModelPhilips Ultrasound, Inc.20200—
+11K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+11K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+11K200655FibroScan® 630Echosens20200—
+11K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+11K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+11K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+11K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+11K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+11K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+11K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+11K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+11K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+11K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+11K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+11K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+11K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+11K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+11K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+11K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+11K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+11K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+11K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+11K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+11K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+11K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+11K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+11K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+11K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+11K173569Ultrasound System 1300Bk Medical Aps20181—
+11K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+11K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+11K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+11K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+11K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+11K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+11K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+11K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+11K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+11K163443Interson USB Ultrasound SystemInterson Corporation20173—
+11K170445Logiq S8GE Healthcare2017191
+11K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+11K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+11K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+11K162549Lumify Ultrasound SystemPhilips Health Care2016436
+11K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+11K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+11K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+11K160357TrinityKoelis20161—
+11K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+11K160420SpeqTSignostics Limited20161—
+11K160524FibroScan 530 CompactEchosens201641—
+11K160182LOGIQ S7 ExpertGE Healthcare2016361
+11K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+11K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+11K143452Logiq P9, Logiq P7GE Healthcare2015131—
+11K141639Voluson S6, Voluson S8GE Healthcare2014151—
+11K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+11K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—