510(k) Report

Devices descending from K946179

931 later devices reach Siemens Sonoline 4XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+10K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+10K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+10K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+10K163443Interson USB Ultrasound SystemInterson Corporation20173—
+10K170445Logiq S8GE Healthcare2017191
+10K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+10K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+10K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+10K162549Lumify Ultrasound SystemPhilips Health Care2016436
+10K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+10K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+10K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+10K160357TrinityKoelis20161—
+10K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+10K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+10K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+10K160420SpeqTSignostics Limited20161—
+10K160524FibroScan 530 CompactEchosens201641—
+10K160182LOGIQ S7 ExpertGE Healthcare2016361
+10K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+10K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+10K143452Logiq P9, Logiq P7GE Healthcare2015131—
+10K141639Voluson S6, Voluson S8GE Healthcare2014151—
+10K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+10K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+10K133533Logiq EGE Healthcare2014149—
+10K133034Logiq F SeriesGE Healthcare2014155—
+10K133431VENUE 50GE Healthcare201360—
+10K131937Voluson I/EGE Healthcare201335—
+10K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+10K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+10K1311184D VIEWGE Healthcare20131—
+10K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+10K122387Voluson P6, Voluson P8GE Healthcare2012201—
+10K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+11K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+11K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+11K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+11K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+11K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+11K2503303mensio WorkstationPie Medical Imaging BV202501
+11K252007BlineSlideDeep Breathe, Inc.20250—
+11K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250120GECHONarnar, LLC20250—
+11K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+11K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+11K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+11K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+11K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+11K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+11K234141AISAP Cardio V1.0Aisap20240—
+11K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+11K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K233734Interson USB Ultrasound SystemInterson Corporation20230—
+11K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+11K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+11K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+11K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+11K231764Ultrasound System 1300Bk Medical Aps202301
+11K230209Sonix HealthOntact Health Co., Ltd.20233—
+11K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+11K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+11K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+11K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+11K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+11K222441Ultrasound System 2300Bk Medical Aps20221—
+11K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+11K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+11K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+11K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+11K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+11K213102ES1 SystemE-Scopics20223—
+11K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+11K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+11K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+11K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+11K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+11K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+11K212035FibroScan 230Echosens20215—
+11K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+11K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+11K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+11K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+11K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+11K200708Vivid iqGe Medical Systems Ultrasound And20203—
+11K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+11K201693DC-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—
+11K201597Liver Incytes, Model 1005Sonic Incytes20204—
+11K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—