510(k) Report

Devices descending from K163691

58 later devices reach HS70A Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+1K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+1K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+1K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+2K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+2K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+2K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+2K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+2K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+2K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+2K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+3K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+3K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+3K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+3K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+3K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+3K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+3K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+3K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+3K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+4K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+4K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+4K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+4K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+4K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+4K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+4K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+4K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+4K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+4K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+5K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+5K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+5K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+5K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+5K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+5K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+5K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+5K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+6K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+6K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+6K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+6K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+6K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+6K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+7K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+7K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+7K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+8K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+8K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+9K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+9K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+9K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+9K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+10K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+10K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+11K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—