510(k) Report

Devices descending from K122387

201 later devices reach Voluson P6, Voluson P8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141675Voluson P6, Voluson P8GE Healthcare201414—
+1K141639Voluson S6, Voluson S8GE Healthcare2014151—
+1K133034Logiq F SeriesGE Healthcare2014155—
+1K131937Voluson I/EGE Healthcare201335—
+2K160162Voluson P6, Voluson P8GE Healthcare201613—
+2K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+2K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+2K160182LOGIQ S7 ExpertGE Healthcare2016361
+2K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+2K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+2K143452Logiq P9, Logiq P7GE Healthcare2015131—
+2K141768Logiq V5/Logiq V3GE Healthcare201457—
+2K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+3K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+3K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+3K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+3K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+3K180535Voluson P6 and Voluson P8GE Healthcare2018121
+3K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+3K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+3K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+3K170521Trinity/3D Prostate SuiteKoelis20170—
+3K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+3K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+3K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+3K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+3K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+3K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+3K152195Logiq S8GE Healthcare201557—
+4K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+4K213689Voluson P6, Voluson P8GE Healthcare20220—
+4K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+4K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+4K200708Vivid iqGe Medical Systems Ultrasound And20203—
+4K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+4K200138Versana PremierGe Medical Systems Ultrasound And20202—
+4K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+4K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+4K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+4K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+4K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+4K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+4K170445Logiq S8GE Healthcare2017191
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+5K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+5K2301796440 MyLabX90Esaote, S.p.A.202341
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K230365Sonio DetectSonio20237—
+5K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+5K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+5K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+5K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+5K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+5K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+5K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K193518KosmosEchoNous, Inc.20201—
+5K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+5K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+5K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+5K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+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—
+5K181783Logiq P9; Logiq P7GE Healthcare2018171
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+6K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+6K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+6K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K242594DeepechoDeepecho20250—
+6K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+6K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+6K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+6K233955Clarius OB AIClarius Mobile Health Corp.20240—
+6K240406Sonio DetectSonio20244—
+6K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—