510(k) Report

Devices descending from K112213

404 later devices reach Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+1K120741Voluson S6, Voluson S8GE Healthcare2012295—
+1K113758Voluson E6/E8/E8EXPERT/E10GE Healthcare2012402—
+2K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+2K141639Voluson S6, Voluson S8GE Healthcare2014151—
+2K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+2K133533Logiq EGE Healthcare2014149—
+2K131937Voluson I/EGE Healthcare201335—
+2K131527Logiq S8GE Healthcare2013219—
+2K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+2K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+2K122387Voluson P6, Voluson P8GE Healthcare2012201—
+2K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc.201298—
+3K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+3K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+3K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+3K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+3K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+3K1619555D ViewerSamsung Medison Co., Ltd.20163—
+3K160357TrinityKoelis20161—
+3K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+3K160182LOGIQ S7 ExpertGE Healthcare2016361
+3K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+3K152195Logiq S8GE Healthcare201557—
+3K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+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—
+3K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+3K141768Logiq V5/Logiq V3GE Healthcare201457—
+3K141675Voluson P6, Voluson P8GE Healthcare201414—
+3K133034Logiq F SeriesGE Healthcare2014155—
+3K133431VENUE 50GE Healthcare201360—
+3K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+3K1311184D VIEWGE Healthcare20131—
+3K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+3K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+4K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+4K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+4K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+4K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+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
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K1808835D ViewerSamsung Medison Co., Ltd.20180—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+4K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+4K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+4K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K1725133D EchoJointvue, LLC20171—
+4K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+4K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+4K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K170521Trinity/3D Prostate SuiteKoelis20170—
+4K170445Logiq S8GE Healthcare2017191
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+4K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+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—
+4K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+4K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+4K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+4K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+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—
+4K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+4K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+4K143601U-LiteSonoscanner Sarl20153—
+4K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+4K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+4K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+4K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+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—