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
+8K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+8K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+8K170445Logiq S8GE Healthcare2017191
+8K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+8K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+8K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+8K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+8K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+8K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+8K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+8K160524FibroScan 530 CompactEchosens201641—
+8K160182LOGIQ S7 ExpertGE Healthcare2016361
+8K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+8K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+8K151904SyncVision SystemVolcano Corporation201521
+8K151485GenesisDornier Medtech America, Inc.20151—
+8K133434Genesis IIDornier Medtech America, Inc.20142—
+8K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+8K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+8K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+8K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+8K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+8K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+8K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+8K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+8K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+8K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+8K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+8K111582Logiq S8GE Healthcare20113673
+8K110943Logiq E9GE Healthcare20114722
+8K103649Voluson S6, Voluson S8GE Healthcare2011296—
+8K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+8K101337A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20101—
+8K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+8K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+8K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+8K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+8K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+9K262390BoneXpertVisiana20260—
+9K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+9K252503Intelligent NRCanon, Inc.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+9K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+9K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+9K250914MediAI-BACrescom Co., Ltd.20250—
+9K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+9K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K243937Accuro 3SRivanna Medical, Inc.20252—
+9K243684BrightHeart View ClassifierBrightheart20251—
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+9K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K2434463DXRGE Medical Systems SCS20250—
+9K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+9K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+9K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+9K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+9K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+9K240645Sonix HealthOntact Health Co., Ltd.20240—
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+9K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+9K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+9K242223SuperSonic HepaVuSupersonic Imagine20240—
+9K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+9K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+9K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+9K233543YSIO X.preeSiemens Medical Solutions20241—
+9K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+9K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+9K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+9K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+9K231995AcuityUDRRadmedix, LLC20230—
+9K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+9K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+9K223830Ultrasound System 2300Bk Medical Aps202306
+9K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+9K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+9K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+9K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—