510(k) Report

Devices descending from K071134

259 later devices reach Sonosite Maxx Series Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+1K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+1K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+1K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+1K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+1K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+2K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+2K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+2K133533Logiq EGE Healthcare2014149—
+2K133431VENUE 50GE Healthcare201360—
+2K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+2K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+2K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+2K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+2K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+2K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+3K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+3K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+3K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+3K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+3K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+3K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+3K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+3K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+3K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+3K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+3K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+3K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+3K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+3K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+3K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+3K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+3K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+3K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+3K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+3K143601U-LiteSonoscanner Sarl20153—
+3K143452Logiq P9, Logiq P7GE Healthcare2015131—
+3K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+3K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+4K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+4K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+4K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+4K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+4K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+4K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+4K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+4K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+4K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+4K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K171164U-Lite EXPSonoscanner20172—
+4K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+4K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+4K160182LOGIQ S7 ExpertGE Healthcare2016361
+4K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+4K152195Logiq S8GE Healthcare201557—
+4K142077MylabgammaEsaote, S.p.A.201453
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+5K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+5K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+5K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+5K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+5K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+5K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+5K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+5K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+5K201988T-LiteSonoscanner20201—
+5K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+5K200708Vivid iqGe Medical Systems Ultrasound And20203—
+5K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+5K200138Versana PremierGe Medical Systems Ultrasound And20202—
+5K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+5K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—