510(k) Report

Devices descending from K052441

629 later devices reach GE Logiq 7 Ultrasound BT05 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+4K143452Logiq P9, Logiq P7GE Healthcare2015131—
+4K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+4K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+4K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+4K141768Logiq V5/Logiq V3GE Healthcare201457—
+4K141639Voluson S6, Voluson S8GE Healthcare2014151—
+4K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+4K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+4K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+4K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+4K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+4K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+4K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+4K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+4K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K111142Echosoft (TM)Echometrix, LLC20120—
+4K122387Voluson P6, Voluson P8GE Healthcare2012201—
+4K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+4K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+4K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+4K103649Voluson S6, Voluson S8GE Healthcare2011296—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+4K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+4K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+5K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+5K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+5K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+5K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+5K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+5K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+5K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+5K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+5K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+5K200708Vivid iqGe Medical Systems Ultrasound And20203—
+5K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+5K200138Versana PremierGe Medical Systems Ultrasound And20202—
+5K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+5K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+5K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+5K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+5K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+5K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+5K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+5K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+5K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+5K1808835D ViewerSamsung Medison Co., Ltd.20180—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+5K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K173555Logiq E10GE Healthcare2017382
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+5K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+5K171594AccuroRivanna Medical, LLC20173—
+5K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+5K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+5K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+5K1725133D EchoJointvue, LLC20171—
+5K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+5K171164U-Lite EXPSonoscanner20172—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K170521Trinity/3D Prostate SuiteKoelis20170—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K163690DC-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—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—