510(k) Report

Devices descending from K944004

654 later devices reach Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+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—
+7K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+7K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+7K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+7K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+7K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+7K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+7K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+7K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+7K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+7K170521Trinity/3D Prostate SuiteKoelis20170—
+7K170133FFR V2.5Philips Volcano201751
+7K163119NaviSuite SSI EditionMedcom GmbH20171—
+7K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+7K170445Logiq S8GE Healthcare2017191
+7K170385CORE M2 Vascular SystemVolcano Corporation20171—
+7K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+7K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+7K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+7K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+7K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+7K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+7K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+7K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+7K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+7K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+7K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+7K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+7K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+7K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+7K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+7K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+7K143601U-LiteSonoscanner Sarl20153—
+7K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+7K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+7K141768Logiq V5/Logiq V3GE Healthcare201457—
+7K141675Voluson P6, Voluson P8GE Healthcare201414—
+7K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+7K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+7K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+7K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+7K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+7K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+8K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+8K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+8K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+8K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+8K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+8K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+8K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+8K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+8K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+8K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+8K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+8K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+8K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,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—
+8K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+8K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+8K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+8K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+8K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+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—
+8K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+8K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+8K203719IntraSight MobileVolcano Corporation202101