510(k) Report

Devices descending from K113156

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+5K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+5K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+5K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181783Logiq P9; Logiq P7GE Healthcare2018171
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+6K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+6K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+6K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+6K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+6K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+6K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+6K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+6K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+6K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+6K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+6K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+6K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+6K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+6K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+6K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+6K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+6K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+6K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K200655FibroScan® 630Echosens20200—
+6K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+6K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+6K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+6K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+7K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+7K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+7K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+7K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+7K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+7K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+7K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+7K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+7K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+7K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+7K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+7K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+7K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+7K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+7K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+7K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+7K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+7K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+7K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+8K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+8K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+8K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+8K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+8K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+8K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+8K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+8K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+8K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+8K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+8K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+8K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+9K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+9K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+9K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+9K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+9K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+9K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+9K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+10K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K242223SuperSonic HepaVuSupersonic Imagine20240—
+10K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+10K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—