510(k) Report

Devices descending from K022824

986 later devices reach Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+5K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+5K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142077MylabgammaEsaote, S.p.A.201453
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+5K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+5K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+5K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+5K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+5K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+5K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+5K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+5K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+5K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+5K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+5K123806FibroscanEchosens201355—
+5K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+5K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K121513Multix FusionSiemens Medical Solution2012324
+5K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+5K120697Eagle Eye Platinum ST CatheterVolcano Corporation201212—
+5K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+5K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+5K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+5K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+5K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+5K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+5K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+5K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+5K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+5K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+5K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+5K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+5K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+5K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+5K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+6K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+6K251417ReVISION 2Argus Cognitive, Inc.20260—
+6K260192DIANAROPCA ApS20260—
+6K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+6K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+6K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+6K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+6K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+6K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+6K250670EchoConfidence (USA)Mycardium AI Limited20250—
+6K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+6K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+6K242359Strain AI (SAI001)Exo, Inc.20240—
+6K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+6K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K233734Interson USB Ultrasound SystemInterson Corporation20230—
+6K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+6K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+6K232501AI Platform (AIP001)Exo, Inc.20231—
+6K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+6K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC20230—
+6K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+6K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+6K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+6K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC20221—
+6K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+6K212376Caas QardiaPie Medical Imaging BV20220—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+6K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+6K212012Follicle ClarityCycle Clarity20221—
+6K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+6K213275EchoGo Core (2.0)Ultromics Limited20211—
+6K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+6K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+6K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+6K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+6K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+6K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+6K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+6K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+6K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+6K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+6K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+6K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+6K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+6K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+6K200603AAA ModelPhilips Ultrasound, Inc.20200—
+6K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K2013523D Auto LAAPhilips Health Care20200—
+6K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—