510(k) Report

Devices descending from K010950

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+11K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+11K213275EchoGo Core (2.0)Ultromics Limited20211—
+11K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+11K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+11K2116563D Echo v1.1Jointvue, LLC20210—
+11K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+11K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+11K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+11K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+11K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+11K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+11K200655FibroScan® 630Echosens20200—
+11K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+11K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+11K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+11K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+11K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+11K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+11K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+11K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+11K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+11K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+11K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+11K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+11K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+11K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+11K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+11K173569Ultrasound System 1300Bk Medical Aps20181—
+11K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+11K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+11K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+11K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+11K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+11K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+11K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+11K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+11K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+11K170445Logiq S8GE Healthcare2017191
+11K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+11K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+11K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+11K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+11K160357TrinityKoelis20161—
+11K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+11K160524FibroScan 530 CompactEchosens201641—
+11K160182LOGIQ S7 ExpertGE Healthcare2016361
+11K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+11K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+11K143452Logiq P9, Logiq P7GE Healthcare2015131—
+11K141639Voluson S6, Voluson S8GE Healthcare2014151—
+11K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+11K133533Logiq EGE Healthcare2014149—
+11K133034Logiq F SeriesGE Healthcare2014155—
+11K133431VENUE 50GE Healthcare201360—
+11K131937Voluson I/EGE Healthcare201335—
+11K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+11K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+11K1311184D VIEWGE Healthcare20131—
+11K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+11K122387Voluson P6, Voluson P8GE Healthcare2012201—
+11K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+12K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+12K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+12K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+12K252007BlineSlideDeep Breathe, Inc.20250—
+12K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243684BrightHeart View ClassifierBrightheart20251—
+12K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+12K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+12K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+12K240645Sonix HealthOntact Health Co., Ltd.20240—
+12K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+12K234141AISAP Cardio V1.0Aisap20240—
+12K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+12K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+12K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+12K222441Ultrasound System 2300Bk Medical Aps20221—
+12K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+12K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+12K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K213102ES1 SystemE-Scopics20223—
+12K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+12K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+12K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+12K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+12K212035FibroScan 230Echosens20215—