510(k) Report

Devices descending from K072786

800 later devices reach Acuson S2000 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+7K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+7K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+7K242223SuperSonic HepaVuSupersonic Imagine20240—
+7K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+7K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+7K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+7K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+7K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+7K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+7K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+7K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+7K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+7K232336ES Series V2E-Scopics20232—
+7K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+7K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+7K223287VelacurSonic Incytes20233—
+7K223830Ultrasound System 2300Bk Medical Aps202306
+7K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+7K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+7K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+7K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+7K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+7K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+7K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+7K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+7K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+7K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+7K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+7K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+7K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+7K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+7K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+7K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+7K211527Exo IrisExo Imaging, Inc.20211—
+7K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+7K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+7K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+7K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+7K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+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—
+7K202422Arietta 65Hitachi Healthcare Americas20200—
+7K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K201768Voluson E10GE Healthcare20204—
+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—
+7K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+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—
+7K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+7K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+7K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+7K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+7K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+7K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+7K191233Arietta 750Hitachi Healthcare Americas201901
+7K190248Arietta 50Hitachi Healthcare Americas20191—
+7K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+7K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+7K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+7K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+7K171594AccuroRivanna Medical, LLC20173—
+7K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K171164U-Lite EXPSonoscanner20172—
+7K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+7K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+7K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+7K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+7K160162Voluson P6, Voluson P8GE Healthcare201613—
+7K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+7K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+7K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+7K133277XARIO 100Toshibamedical Systems Corporation20142—
+8K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+8K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+8K260589ES-SeriesE-Scopics20260—
+8K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+8K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+8K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+8K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+8K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—