510(k) Report

Devices descending from K964309

1,024 later devices reach Sonos 2000, Sonos 2500 (M2406 a) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+12K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+12K160357TrinityKoelis20161—
+12K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+12K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+12K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+12K160524FibroScan 530 CompactEchosens201641—
+12K160182LOGIQ S7 ExpertGE Healthcare2016361
+12K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+12K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+12K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+12K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+12K143452Logiq P9, Logiq P7GE Healthcare2015131—
+12K141639Voluson S6, Voluson S8GE Healthcare2014151—
+12K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+12K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+12K133533Logiq EGE Healthcare2014149—
+12K133034Logiq F SeriesGE Healthcare2014155—
+12K133431VENUE 50GE Healthcare201360—
+12K131937Voluson I/EGE Healthcare201335—
+12K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+12K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+12K1311184D VIEWGE Healthcare20131—
+12K122387Voluson P6, Voluson P8GE Healthcare2012201—
+12K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K260192DIANAROPCA ApS20260—
+13K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+13K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+13K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+13K2503303mensio WorkstationPie Medical Imaging BV202501
+13K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+13K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K250670EchoConfidence (USA)Mycardium AI Limited20250—
+13K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+13K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+13K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+13K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+13K242359Strain AI (SAI001)Exo, Inc.20240—
+13K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+13K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+13K242223SuperSonic HepaVuSupersonic Imagine20240—
+13K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+13K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+13K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+13K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+13K232501AI Platform (AIP001)Exo, Inc.20231—
+13K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+13K231764Ultrasound System 1300Bk Medical Aps202301
+13K230209Sonix HealthOntact Health Co., Ltd.20233—
+13K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+13K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+13K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+13K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+13K222441Ultrasound System 2300Bk Medical Aps20221—
+13K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+13K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+13K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+13K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+13K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+13K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+13K213102ES1 SystemE-Scopics20223—
+13K213275EchoGo Core (2.0)Ultromics Limited20211—
+13K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+13K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+13K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+13K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+13K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+13K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+13K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+13K212035FibroScan 230Echosens20215—
+13K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+13K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+13K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+13K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+13K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+13K201693DC-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—
+13K201597Liver Incytes, Model 1005Sonic Incytes20204—
+13K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+13K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+13K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+13K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+13K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+13K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+13K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+13K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+13K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+13K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+13K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+13K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+13K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+13K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+13K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+13K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+13K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+13K173555Logiq E10GE Healthcare2017382
+13K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+13K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+13K172142FibroScan 430 Mini+Echosens20170—
+13K170521Trinity/3D Prostate SuiteKoelis20170—