510(k) Report

Devices descending from K172342

18 later devices reach Voluson E6, Voluson E8, Voluson E10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+2K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+2K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+3K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+3K201768Voluson E10GE Healthcare20204—
+3K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+4K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+4K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+4K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+4K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+5K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+5K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+6K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+6K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+7K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+7K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—