510(k) Report

Devices descending from K063085

838 later devices reach Modification to Acuson Sequoia Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+8K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+8K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+8K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+8K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+8K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+8K202422Arietta 65Hitachi Healthcare Americas20200—
+8K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K201768Voluson E10GE Healthcare20204—
+8K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K200138Versana PremierGe Medical Systems Ultrasound And20202—
+8K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+8K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+8K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+8K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+8K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+8K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+8K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+8K191233Arietta 750Hitachi Healthcare Americas201901
+8K190248Arietta 50Hitachi Healthcare Americas20191—
+8K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+8K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+8K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+8K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+8K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+8K171594AccuroRivanna Medical, LLC20173—
+8K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+8K171164U-Lite EXPSonoscanner20172—
+8K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+8K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+8K160162Voluson P6, Voluson P8GE Healthcare201613—
+8K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+8K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+8K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+8K133277XARIO 100Toshibamedical Systems Corporation20142—
+9K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+9K260589ES-SeriesE-Scopics20260—
+9K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+9K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+9K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+9K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+9K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+9K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K243937Accuro 3SRivanna Medical, Inc.20252—
+9K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+9K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+9K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+9K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+9K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+9K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+9K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+9K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+9K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+9K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+9K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+9K232459VelacurSonic Incytes20232—
+9K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+9K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+9K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+9K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+9K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220851VenueGE Medical Systems20223—
+9K220848Venue FitGE Medical Systems202241
+9K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+9K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K220295Arietta 50Fujifilm Healthcare Corporation20220—
+9K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+9K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+9K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+9K211488Logiq E10GE Healthcare202111—
+9K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+9K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+9K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K201988T-LiteSonoscanner20201—
+9K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+9K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—