510(k) Report

Devices descending from K022567

1,069 later devices reach Sequoia Signature II Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+10K170445Logiq S8GE Healthcare2017191
+10K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+10K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+10K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+10K160357TrinityKoelis20161—
+10K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+10K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+10K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+10K160524FibroScan 530 CompactEchosens201641—
+10K160182LOGIQ S7 ExpertGE Healthcare2016361
+10K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+10K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+10K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+10K143452Logiq P9, Logiq P7GE Healthcare2015131—
+10K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+10K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+10K141639Voluson S6, Voluson S8GE Healthcare2014151—
+10K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+10K133533Logiq EGE Healthcare2014149—
+10K133034Logiq F SeriesGE Healthcare2014155—
+10K133277XARIO 100Toshibamedical Systems Corporation20142—
+10K133431VENUE 50GE Healthcare201360—
+10K131937Voluson I/EGE Healthcare201335—
+10K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+10K1311184D VIEWGE Healthcare20131—
+10K122387Voluson P6, Voluson P8GE Healthcare2012201—
+10K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+11K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+11K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+11K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+11K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+11K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+11K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+11K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+11K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+11K223830Ultrasound System 2300Bk Medical Aps202306
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+11K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+11K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+11K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+11K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K213102ES1 SystemE-Scopics20223—
+11K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+11K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+11K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+11K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+11K212035FibroScan 230Echosens20215—
+11K211337DC-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—
+11K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+11K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+11K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+11K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+11K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+11K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+11K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+11K201597Liver Incytes, Model 1005Sonic Incytes20204—
+11K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+11K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+11K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+11K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+11K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+11K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+11K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+11K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+11K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+11K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+11K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+11K172256SoftVueDelphinus Medical Technologies20180—
+11K173555Logiq E10GE Healthcare2017382
+11K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+11K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+11K172142FibroScan 430 Mini+Echosens20170—
+11K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+11K170521Trinity/3D Prostate SuiteKoelis20170—
+11K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+11K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—