510(k) Report

Devices descending from K022303

1,155 later devices reach Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+7K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+7K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+7K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+7K111582Logiq S8GE Healthcare20113673
+7K110943Logiq E9GE Healthcare20114722
+7K103649Voluson S6, Voluson S8GE Healthcare2011296—
+7K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+7K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+7K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+7K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+7K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+7K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K262390BoneXpertVisiana20260—
+8K251417ReVISION 2Argus Cognitive, Inc.20260—
+8K260192DIANAROPCA ApS20260—
+8K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+8K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+8K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+8K252503Intelligent NRCanon, Inc.20260—
+8K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+8K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+8K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+8K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+8K250914MediAI-BACrescom Co., Ltd.20250—
+8K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+8K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K243937Accuro 3SRivanna Medical, Inc.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+8K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+8K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+8K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+8K2434463DXRGE Medical Systems SCS20250—
+8K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+8K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+8K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+8K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+8K242359Strain AI (SAI001)Exo, Inc.20240—
+8K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+8K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+8K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+8K242223SuperSonic HepaVuSupersonic Imagine20240—
+8K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+8K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+8K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+8K233543YSIO X.preeSiemens Medical Solutions20241—
+8K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+8K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+8K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+8K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+8K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+8K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+8K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+8K232501AI Platform (AIP001)Exo, Inc.20231—
+8K231995AcuityUDRRadmedix, LLC20230—
+8K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+8K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+8K223830Ultrasound System 2300Bk Medical Aps202306
+8K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+8K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+8K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+8K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+8K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+8K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+8K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+8K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+8K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+8K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+8K221335D²RS and D²RS 9090Stephanix20220—
+8K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+8K212376Caas QardiaPie Medical Imaging BV20220—
+8K220871NautilusDornier Medtech America, Inc.20220—
+8K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+8K213102ES1 SystemE-Scopics20223—
+8K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+8K213275EchoGo Core (2.0)Ultromics Limited20211—
+8K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+8K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+8K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+8K211527Exo IrisExo Imaging, Inc.20211—
+8K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K212035FibroScan 230Echosens20215—
+8K211337DC-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—
+8K2116563D Echo v1.1Jointvue, LLC20210—