510(k) Report

Devices descending from K050034

921 later devices reach Sonoline Antares Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211527Exo IrisExo Imaging, Inc.20211—
+9K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+9K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+9K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+9K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+9K202422Arietta 65Hitachi Healthcare Americas20200—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201768Voluson E10GE Healthcare20204—
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K200138Versana PremierGe Medical Systems Ultrasound And20202—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+9K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+9K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+9K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+9K191233Arietta 750Hitachi Healthcare Americas201901
+9K190248Arietta 50Hitachi Healthcare Americas20191—
+9K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+9K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+9K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+9K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+9K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+9K171594AccuroRivanna Medical, LLC20173—
+9K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+9K171164U-Lite EXPSonoscanner20172—
+9K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+9K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+9K160162Voluson P6, Voluson P8GE Healthcare201613—
+9K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+9K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+9K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+9K133277XARIO 100Toshibamedical Systems Corporation20142—
+10K262390BoneXpertVisiana20260—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K260589ES-SeriesE-Scopics20260—
+10K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+10K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+10K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K250914MediAI-BACrescom Co., Ltd.20250—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+10K243937Accuro 3SRivanna Medical, Inc.20252—
+10K243684BrightHeart View ClassifierBrightheart20251—
+10K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+10K240645Sonix HealthOntact Health Co., Ltd.20240—
+10K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+10K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+10K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+10K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+10K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+10K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+10K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+10K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K232459VelacurSonic Incytes20232—
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+10K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+10K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+10K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+10K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+10K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+10K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+10K220851VenueGE Medical Systems20223—
+10K220848Venue FitGE Medical Systems202241
+10K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+10K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K220295Arietta 50Fujifilm Healthcare Corporation20220—
+10K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+10K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+10K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+10K211488Logiq E10GE Healthcare202111—
+10K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+10K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+10K201988T-LiteSonoscanner20201—
+10K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—