510(k) Report

Devices descending from K063138

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+8K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+8K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+8K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+8K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+8K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+8K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+8K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+8K143601U-LiteSonoscanner Sarl20153—
+8K141768Logiq V5/Logiq V3GE Healthcare201457—
+8K141675Voluson P6, Voluson P8GE Healthcare201414—
+8K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+8K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+8K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+8K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+9K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+9K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+9K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K242223SuperSonic HepaVuSupersonic Imagine20240—
+9K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+9K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+9K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+9K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+9K232336ES Series V2E-Scopics20232—
+9K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K223287VelacurSonic Incytes20233—
+9K223830Ultrasound System 2300Bk Medical Aps202306
+9K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+9K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+9K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+9K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+9K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+9K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+9K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+9K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+9K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+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—
+9K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+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
+9K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+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—
+9K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+9K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K200138Versana PremierGe Medical Systems Ultrasound And20202—
+9K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+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—
+9K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+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—
+9K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+9K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+9K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+9K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821