510(k) Report

Devices descending from K150478

97 later devices reach A35 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+1K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+1K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+1K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+2K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+2K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+2K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+2K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+2K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+2K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+2K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+2K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+2K1619555D ViewerSamsung Medison Co., Ltd.20163—
+2K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+2K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+3K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+3K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+3K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+3K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+3K1808835D ViewerSamsung Medison Co., Ltd.20180—
+3K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+3K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+3K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+3K1725133D EchoJointvue, LLC20171—
+3K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+3K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+3K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+3K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+4K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+4K2116563D Echo v1.1Jointvue, LLC20210—
+4K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+4K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+4K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+4K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+4K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+4K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+4K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+4K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+5K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+5K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+5K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+5K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+5K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+5K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+5K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+5K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+5K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+5K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+6K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+6K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+6K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+6K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+6K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+6K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+6K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+6K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+6K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+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—
+7K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+7K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+7K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+7K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+7K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+7K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+7K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+8K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+8K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+8K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+8K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+9K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+9K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+10K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+10K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+10K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+10K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+11K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+11K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+12K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—