510(k) Report

Devices descending from K032114

1,003 later devices reach Sequoia 8.0 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+11K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+11K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+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—
+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—
+11K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+11K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+11K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+11K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+11K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+11K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+11K143601U-LiteSonoscanner Sarl20153—
+11K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+11K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+11K141768Logiq V5/Logiq V3GE Healthcare201457—
+11K141675Voluson P6, Voluson P8GE Healthcare201414—
+11K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+11K133277XARIO 100Toshibamedical Systems Corporation20142—
+11K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+12K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+12K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+12K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+12K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+12K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+12K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+12K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+12K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+12K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+12K232336ES Series V2E-Scopics20232—
+12K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K223287VelacurSonic Incytes20233—
+12K223830Ultrasound System 2300Bk Medical Aps202306
+12K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+12K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+12K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+12K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+12K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+12K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+12K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+12K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+12K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+12K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+12K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+12K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+12K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+12K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+12K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+12K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+12K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+12K202422Arietta 65Hitachi Healthcare Americas20200—
+12K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+12K200138Versana PremierGe Medical Systems Ultrasound And20202—
+12K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+12K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+12K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+12K191233Arietta 750Hitachi Healthcare Americas201901
+12K190248Arietta 50Hitachi Healthcare Americas20191—
+12K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+12K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+12K172256SoftVueDelphinus Medical Technologies20180—
+12K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+12K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+12K171164U-Lite EXPSonoscanner20172—
+12K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+12K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+12K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+12K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+12K160162Voluson P6, Voluson P8GE Healthcare201613—
+12K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+12K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+13K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K260589ES-SeriesE-Scopics20260—
+13K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+13K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+13K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—