510(k) Report

Devices descending from K063580

129 later devices reach Sonoace X8 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+1K093714Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2009111—
+1K081676Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd.2008105—
+1K080800Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2008124—
+1K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2007125—
+2K113184Logicscan 64 Logicscan 128Telemed20124—
+2K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011102—
+2K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011108—
+2K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010110—
+2K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd.2010104—
+2K093849Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2010112—
+2K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2009123—
+3K211248ArtUsTelemed20220—
+3K173486NTU-USB Ultrasound USB BoxNational Taiwan University20180—
+3K163121SmartUs EXT-1M/3MTelemed20172—
+3K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201398—
+3K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013101—
+3K122583Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2012108—
+3K112339Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011109—
+3K103397Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd.2011110—
+3K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd.2011103—
+3K101455Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+4K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+4K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+4K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+4K132861Ugeo H60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+4K130803Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013106—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+5K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+6K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+6K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+6K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+6K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+6K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+6K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+6K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+7K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+7K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+7K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+7K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+7K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+7K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+7K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+7K1725133D EchoJointvue, LLC20171—
+7K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+8K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+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—
+8K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+8K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+8K2116563D Echo v1.1Jointvue, LLC20210—
+8K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+8K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+8K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+8K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+8K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+9K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—