510(k) Report

Devices descending from K122536

69 later devices reach Amcad-UT Detection Model 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+1K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+2K203555AmCAD-UTAmcad Biomed Corporation20212—
+2K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+2K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+2K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+2K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+3K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+3K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+3K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+3K1808835D ViewerSamsung Medison Co., Ltd.20180—
+3K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+3K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+3K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+3K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+3K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+4K250484PIUR tUS insidePiur Imaging GmbH20250—
+4K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+4K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+4K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+5K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+5K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+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—
+5K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+5K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+5K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+5K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+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—
+6K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+6K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+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—
+6K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+7K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+7K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+7K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+7K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+7K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+7K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+7K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+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—
+8K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+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—