510(k) Report

Devices descending from K123564

323 later devices reach Logiq E9 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+4K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+4K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+4K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+4K1808835D ViewerSamsung Medison Co., Ltd.20180—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K173555Logiq E10GE Healthcare2017382
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K1725133D EchoJointvue, LLC20171—
+4K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+4K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+4K171164U-Lite EXPSonoscanner20172—
+4K170841BiopSee, Mobile USMedcom GmbH20170—
+4K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+4K170521Trinity/3D Prostate SuiteKoelis20170—
+4K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+4K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+4K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+4K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+4K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+5K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+5K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+5K2301796440 MyLabX90Esaote, S.p.A.202341
+5K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+5K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+5K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+5K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+5K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K220851VenueGE Medical Systems20223—
+5K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+5K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+5K2116563D Echo v1.1Jointvue, LLC20210—
+5K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+5K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+5K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+5K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+5K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+5K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+5K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+5K201988T-LiteSonoscanner20201—
+5K201768Voluson E10GE Healthcare20204—
+5K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+5K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+5K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+5K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+5K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+5K200655FibroScan® 630Echosens20200—
+5K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+5K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+5K200138Versana PremierGe Medical Systems Ultrasound And20202—
+5K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+5K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+5K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+5K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+5K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+5K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+5K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+5K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+5K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+5K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+5K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+5K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+6K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+6K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+6K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+6K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+6K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+6K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+6K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K242223SuperSonic HepaVuSupersonic Imagine20240—
+6K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+6K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—