510(k) Report

Devices descending from K940942

737 later devices reach Combison 530 Diagnostic Ultrasound Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K200138Versana PremierGe Medical Systems Ultrasound And20202—
+7K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+7K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+7K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+7K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K181637DC-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—
+7K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+7K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+7K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+7K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+7K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+7K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+7K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+7K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+7K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+7K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+7K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+7K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+7K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+7K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+7K170521Trinity/3D Prostate SuiteKoelis20170—
+7K163119NaviSuite SSI EditionMedcom GmbH20171—
+7K170445Logiq S8GE Healthcare2017191
+7K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+7K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+7K161999AixplorerSupersonic Imagine201620—
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+7K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160357TrinityKoelis20161—
+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—
+7K151255Navigator Aesthetic Delivery SystemCarticept Medical, Inc.20150—
+7K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+7K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+7K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+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
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+7K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+7K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+7K141639Voluson S6, Voluson S8GE Healthcare2014151—
+7K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+7K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+7K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+7K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+7K133034Logiq F SeriesGE Healthcare2014155—
+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—
+7K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+7K122387Voluson P6, Voluson P8GE Healthcare2012201—
+7K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+7K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+8K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+8K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+8K251673X9 Ultrasound SystemX9, Inc.20250—
+8K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.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—
+8K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+8K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+8K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—
+8K232285U-Lite PROSonoscanner Sarl20240—
+8K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+8K223830Ultrasound System 2300Bk Medical Aps202306
+8K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+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—
+8K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+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—