510(k) Report

Devices descending from K010950

994 later devices reach Cypress System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+12K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+12K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+12K201597Liver Incytes, Model 1005Sonic Incytes20204—
+12K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+12K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+12K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+12K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+12K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+12K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+12K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+12K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+12K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+12K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+12K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+12K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+12K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+12K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+12K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+12K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+12K173555Logiq E10GE Healthcare2017382
+12K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+12K172142FibroScan 430 Mini+Echosens20170—
+12K170521Trinity/3D Prostate SuiteKoelis20170—
+12K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+12K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+12K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+12K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+12K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+12K143601U-LiteSonoscanner Sarl20153—
+12K141768Logiq V5/Logiq V3GE Healthcare201457—
+12K141675Voluson P6, Voluson P8GE Healthcare201414—
+12K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+12K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+12K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+12K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+13K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+13K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+13K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+13K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+13K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+13K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+13K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+13K251456BrightHeart View ClassifierBrightheart20250—
+13K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+13K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+13K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+13K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+13K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+13K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+13K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+13K232336ES Series V2E-Scopics20232—
+13K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+13K223287VelacurSonic Incytes20233—
+13K223830Ultrasound System 2300Bk Medical Aps202306
+13K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+13K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+13K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+13K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+13K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+13K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+13K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+13K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+13K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+13K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+13K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+13K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+13K202422Arietta 65Hitachi Healthcare Americas20200—
+13K201768Voluson E10GE Healthcare20204—
+13K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+13K200138Versana PremierGe Medical Systems Ultrasound And20202—
+13K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+13K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+13K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+13K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+13K191233Arietta 750Hitachi Healthcare Americas201901
+13K190248Arietta 50Hitachi Healthcare Americas20191—
+13K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+13K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+13K171164U-Lite EXPSonoscanner20172—
+13K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+13K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+13K160162Voluson P6, Voluson P8GE Healthcare201613—
+13K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+13K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+13K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+13K133277XARIO 100Toshibamedical Systems Corporation20142—
+14K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+14K260589ES-SeriesE-Scopics20260—
+14K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+14K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+14K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+14K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+14K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—