510(k) Report

Devices descending from K062247

687 later devices reach HD11 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+6K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+6K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+6K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+6K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+6K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+6K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+6K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+6K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+6K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+6K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+6K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+6K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+6K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+6K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+6K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+6K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+6K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+6K143601U-LiteSonoscanner Sarl20153—
+6K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+6K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+6K141768Logiq V5/Logiq V3GE Healthcare201457—
+6K141675Voluson P6, Voluson P8GE Healthcare201414—
+6K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+6K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+6K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+6K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+6K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+7K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+7K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+7K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+7K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+7K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+7K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+7K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+7K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+7K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+7K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+7K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+7K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+7K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+7K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+7K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+7K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+7K211527Exo IrisExo Imaging, Inc.20211—
+7K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+7K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+7K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+7K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+7K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+7K200138Versana PremierGe Medical Systems Ultrasound And20202—
+7K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+7K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+7K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+7K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+7K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+7K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+7K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+7K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+7K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+7K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+7K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+7K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+7K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K173555Logiq E10GE Healthcare2017382