510(k) Report

Devices descending from K113156

216 later devices reach Sonosite Edge Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+1K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+1K133533Logiq EGE Healthcare2014149—
+1K133431VENUE 50GE Healthcare201360—
+1K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+1K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+2K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+2K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+2K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+2K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+2K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+2K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+2K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+2K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+2K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+2K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+2K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+2K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+2K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+2K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+2K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+2K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+2K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+2K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+2K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+2K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+2K143601U-LiteSonoscanner Sarl20153—
+2K143452Logiq P9, Logiq P7GE Healthcare2015131—
+2K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+3K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+3K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+3K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+3K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+3K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+3K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+3K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+3K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+3K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+3K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+3K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+3K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+3K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+3K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+3K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+3K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+3K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+3K171164U-Lite EXPSonoscanner20172—
+3K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+3K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+3K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+3K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+3K160182LOGIQ S7 ExpertGE Healthcare2016361
+3K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+3K152195Logiq S8GE Healthcare201557—
+4K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+4K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+4K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+4K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+4K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+4K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+4K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+4K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+4K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+4K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+4K201988T-LiteSonoscanner20201—
+4K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+4K200708Vivid iqGe Medical Systems Ultrasound And20203—
+4K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+4K200138Versana PremierGe Medical Systems Ultrasound And20202—
+4K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+4K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K170521Trinity/3D Prostate SuiteKoelis20170—
+4K170445Logiq S8GE Healthcare2017191
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+4K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+5K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+5K232285U-Lite PROSonoscanner Sarl20240—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+5K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+5K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+5K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+5K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K220851VenueGE Medical Systems20223—
+5K220848Venue FitGE Medical Systems202241
+5K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+5K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+5K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+5K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+5K211527Exo IrisExo Imaging, Inc.20211—