510(k) Report

Devices descending from K042055

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+9K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+9K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+9K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+9K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+9K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+9K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+9K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K2116563D Echo v1.1Jointvue, LLC20210—
+9K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+9K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+9K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+9K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+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
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+9K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+9K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+9K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+9K200655FibroScan® 630Echosens20200—
+9K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+9K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+9K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+9K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+9K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+9K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+9K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+9K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+9K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+9K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+9K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+9K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+9K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+9K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+9K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+9K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+9K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+9K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+9K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+9K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+9K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+9K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+9K173569Ultrasound System 1300Bk Medical Aps20181—
+9K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+9K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+9K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+9K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+9K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+9K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+9K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+9K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+9K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+9K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+9K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+9K170445Logiq S8GE Healthcare2017191
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+9K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+9K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+9K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+9K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+9K160357TrinityKoelis20161—
+9K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+9K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+9K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+9K160524FibroScan 530 CompactEchosens201641—
+9K160182LOGIQ S7 ExpertGE Healthcare2016361
+9K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+9K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+9K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+9K143452Logiq P9, Logiq P7GE Healthcare2015131—