510(k) Report

Devices descending from K020353

1,026 later devices reach Omnia X/XS Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+7K151255Navigator Aesthetic Delivery SystemCarticept Medical, Inc.20150—
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+7K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+7K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+7K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+7K150239FibroScanEchosens201525—
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+7K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+7K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+7K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+7K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+7K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+7K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+7K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+7K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+7K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+7K141639Voluson S6, Voluson S8GE Healthcare2014151—
+7K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+7K140808Q-StationPhilips Ultrasound, Inc.201402
+7K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+7K133034Logiq F SeriesGE Healthcare2014155—
+7K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+7K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+7K131937Voluson I/EGE Healthcare201335—
+7K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+7K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+7K1311184D VIEWGE Healthcare20131—
+7K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+7K123806FibroscanEchosens201355—
+7K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+7K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+7K122387Voluson P6, Voluson P8GE Healthcare2012201—
+7K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+7K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+7K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+7K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+7K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+8K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+8K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+8K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+8K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+8K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+8K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+8K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+8K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+8K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K232285U-Lite PROSonoscanner Sarl20240—
+8K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+8K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+8K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+8K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K223830Ultrasound System 2300Bk Medical Aps202306
+8K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+8K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+8K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+8K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+8K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+8K220956Libby Echo:PrioDyad Medical, Inc.20221—
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K220851VenueGE Medical Systems20223—
+8K220848Venue FitGE Medical Systems202241
+8K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+8K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+8K211527Exo IrisExo Imaging, Inc.20211—
+8K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+8K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+8K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+8K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+8K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+8K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+8K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+8K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+8K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+8K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+8K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—