510(k) Report

Devices descending from K103649

296 later devices reach Voluson S6, Voluson S8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120741Voluson S6, Voluson S8GE Healthcare2012295—
+2K141639Voluson S6, Voluson S8GE Healthcare2014151—
+2K133533Logiq EGE Healthcare2014149—
+2K131937Voluson I/EGE Healthcare201335—
+2K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+2K122387Voluson P6, Voluson P8GE Healthcare2012201—
+3K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+3K160182LOGIQ S7 ExpertGE Healthcare2016361
+3K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+3K143452Logiq P9, Logiq P7GE Healthcare2015131—
+3K141768Logiq V5/Logiq V3GE Healthcare201457—
+3K141675Voluson P6, Voluson P8GE Healthcare201414—
+3K133034Logiq F SeriesGE Healthcare2014155—
+3K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+4K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+4K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+4K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+4K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+4K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K170521Trinity/3D Prostate SuiteKoelis20170—
+4K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+4K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+4K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+4K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+4K160162Voluson P6, Voluson P8GE Healthcare201613—
+4K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+4K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+4K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+4K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+4K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+4K152195Logiq S8GE Healthcare201557—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+4K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+5K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+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—
+5K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+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—
+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—
+5K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+5K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+5K1808835D ViewerSamsung Medison Co., Ltd.20180—
+5K180535Voluson P6 and Voluson P8GE Healthcare2018121
+5K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+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—
+5K170445Logiq S8GE Healthcare2017191
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+5K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+5K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+5K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+6K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+6K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+6K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—