510(k) Report

Devices descending from K093563

588 later devices reach IU22 Ultrasound System and Transducers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+3K123806FibroscanEchosens201355—
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+4K260748ES-SeriesE-Scopics20260—
+4K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+4K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+4K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+4K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+4K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+4K201990DC-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—
+4K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+4K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+4K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+4K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+4K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+4K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+4K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+4K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+4K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+4K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+4K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+4K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+4K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+4K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+4K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+4K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+4K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+4K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+4K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+4K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+4K163443Interson USB Ultrasound SystemInterson Corporation20173—
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+4K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+4K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K162549Lumify Ultrasound SystemPhilips Health Care2016436
+4K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+4K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+4K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+4K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+4K1619555D ViewerSamsung Medison Co., Ltd.20163—
+4K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+4K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+4K160420SpeqTSignostics Limited20161—
+4K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+4K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+4K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+4K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+4K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+4K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+4K152195Logiq S8GE Healthcare201557—
+4K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150949FibroScanEchosens201542—
+4K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+4K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+4K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+5K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+5K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+5K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+5K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+5K233734Interson USB Ultrasound SystemInterson Corporation20230—
+5K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+5K2301796440 MyLabX90Esaote, S.p.A.202341
+5K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+5K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+5K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+5K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+5K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+5K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+5K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+5K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+5K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+5K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—