510(k) Report

Devices descending from K041688

708 later devices reach GE Voluson 730 Pro/Expert Untrasound BT04 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K113758Voluson E6/E8/E8EXPERT/E10GE Healthcare2012402—
+4K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+4K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+4K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+4K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+4K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+4K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+5K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+5K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+5K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+5K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+5K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+5K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+5K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+5K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+5K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+5K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+5K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+5K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+5K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+5K170521Trinity/3D Prostate SuiteKoelis20170—
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+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—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K161999AixplorerSupersonic Imagine201620—
+5K161960bk2300Bk Medical Aps20165—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+5K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+5K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+5K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+5K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+5K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+5K160162Voluson P6, Voluson P8GE Healthcare201613—
+5K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+5K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+5K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+5K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+5K152195Logiq S8GE Healthcare201557—
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+5K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+5K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+5K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+5K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+5K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+5K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+5K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+5K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+5K131527Logiq S8GE Healthcare2013219—
+5K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+5K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+5K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+5K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc.201298—
+5K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+5K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+5K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+5K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+5K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+6K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+6K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—