510(k) Report

Devices descending from K863700

672 later devices reach RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+11K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+11K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+11K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+11K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+11K170521Trinity/3D Prostate SuiteKoelis20170—
+11K163119NaviSuite SSI EditionMedcom GmbH20171—
+11K170445Logiq S8GE Healthcare2017191
+11K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+11K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+11K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+11K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+11K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+11K160162Voluson P6, Voluson P8GE Healthcare201613—
+11K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+11K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+11K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+11K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+11K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+12K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+12K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+12K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+12K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+12K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+12K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+12K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+12K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+12K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+12K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+12K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+12K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+12K232285U-Lite PROSonoscanner Sarl20240—
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+12K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+12K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+12K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+12K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+12K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+12K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+12K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+12K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+12K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+12K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+12K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+12K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+12K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+12K2116563D Echo v1.1Jointvue, LLC20210—
+12K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+12K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+12K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+12K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+12K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+12K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+12K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+12K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+12K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+12K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+12K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+12K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+12K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+12K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+12K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+12K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+12K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+12K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+12K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+12K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+12K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+12K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+12K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+12K181783Logiq P9; Logiq P7GE Healthcare2018171
+12K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+12K180535Voluson P6 and Voluson P8GE Healthcare2018121
+12K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+12K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+12K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+12K173555Logiq E10GE Healthcare2017382
+12K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+12K170841BiopSee, Mobile USMedcom GmbH20170—
+12K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+12K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+12K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+13K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+13K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+13K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+13K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+13K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+13K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+13K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+13K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—