510(k) Report

Devices descending from K160184

55 later devices reach Voluson S6, Voluson S8, Voluson S10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+1K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+1K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+2K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+2K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+2K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+2K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+2K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+2K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+2K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+2K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+3K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+3K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+3K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+3K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+3K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+3K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+3K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+3K200708Vivid iqGe Medical Systems Ultrasound And20203—
+3K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+3K200138Versana PremierGe Medical Systems Ultrasound And20202—
+3K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+3K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+3K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+3K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+4K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+4K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+4K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+4K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K220851VenueGE Medical Systems20223—
+4K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+4K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+4K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+4K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+4K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+5K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+5K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+5K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+5K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+5K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+5K220848Venue FitGE Medical Systems202241
+5K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+5K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+6K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+6K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+6K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+6K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+6K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+7K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+7K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+8K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—