510(k) Report

Devices descending from K002470

1,238 later devices reach M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+9K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+9K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+9K221335D²RS and D²RS 9090Stephanix20220—
+9K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K220871NautilusDornier Medtech America, Inc.20220—
+9K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+9K213102ES1 SystemE-Scopics20223—
+9K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+9K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+9K211527Exo IrisExo Imaging, Inc.20211—
+9K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+9K212035FibroScan 230Echosens20215—
+9K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+9K2116563D Echo v1.1Jointvue, LLC20210—
+9K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+9K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+9K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+9K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+9K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+9K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+9K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+9K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+9K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+9K201768Voluson E10GE Healthcare20204—
+9K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+9K201597Liver Incytes, Model 1005Sonic Incytes20204—
+9K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+9K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+9K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+9K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+9K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+9K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+9K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+9K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+9K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+9K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+9K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+9K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+9K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+9K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+9K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+9K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+9K173555Logiq E10GE Healthcare2017382
+9K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+9K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+9K172142FibroScan 430 Mini+Echosens20170—
+9K163505Arietta PrecisionHitachi, Ltd.20170—
+9K170521Trinity/3D Prostate SuiteKoelis20170—
+9K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+9K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+9K162583Aloka Lisendo 880Hitachi, Ltd.201602
+9K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+9K161756SyncVision SystemVolcano Corporation201611
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+9K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+9K131527Logiq S8GE Healthcare2013219—
+9K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+9K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+9K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+9K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+9K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+9K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+9K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+9K120741Voluson S6, Voluson S8GE Healthcare2012295—
+9K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+10K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K253452Accuro 3SRivanna Medical, Inc.20260—
+10K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+10K254021Accuro XVRivanna Medical, Inc.20260—
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K251199Allia MoveoGE Medical Systems SCS202501
+10K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+10K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+10K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250738YSIO X.preeSiemens Medical Solutions20250—
+10K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+10K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+10K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K251456BrightHeart View ClassifierBrightheart20250—
+10K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—