510(k) Report

Devices descending from K031663

1,003 later devices reach GE Vivid 7, Model FC0003XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+4K170521Trinity/3D Prostate SuiteKoelis20170—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+4K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+4K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+4K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+4K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+4K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+4K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+4K141639Voluson S6, Voluson S8GE Healthcare2014151—
+4K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+4K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+4K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+4K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K140153Ventripoint Medical SystemVentripoint, Inc.20142—
+4K133533Logiq EGE Healthcare2014149—
+4K133034Logiq F SeriesGE Healthcare2014155—
+4K133431VENUE 50GE Healthcare201360—
+4K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+4K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+4K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+4K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+4K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+4K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+4K123894GE EchopacGe Vingmed Ultrasound AS20139—
+4K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+4K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+4K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+4K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+4K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+4K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+4K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+4K120741Voluson S6, Voluson S8GE Healthcare2012295—
+4K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+4K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011100—
+4K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+4K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+4K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+4K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+4K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+4K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+4K083597Sonowand InviteSonowand AS20093—
+4K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+4K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+4K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+4K082135ShowcaseTrillium Technology, Inc.20080—
+4K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+4K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+4K070515A-View Basic and PlusCordatec N.V.20071—
+4K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+4K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+4K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+4K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+4K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.20068383
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+5K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+5K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+5K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+5K211527Exo IrisExo Imaging, Inc.20211—
+5K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+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—
+5K201768Voluson E10GE Healthcare20204—
+5K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+5K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+5K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K200708Vivid iqGe Medical Systems Ultrasound And20203—
+5K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+5K200655FibroScan® 630Echosens20200—
+5K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+5K200138Versana PremierGe Medical Systems Ultrasound And20202—
+5K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+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—
+5K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+5K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+5K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+5K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+5K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—