510(k) Report

Devices descending from K993398

987 later devices reach Echo View, Easy View, Omni View through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+6K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+6K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+6K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+6K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+6K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+6K142077MylabgammaEsaote, S.p.A.201453
+6K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+6K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+6K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+6K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+6K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+6K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+6K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+6K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+6K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+6K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+6K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+6K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+6K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+6K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+6K123806FibroscanEchosens201355—
+6K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+6K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+6K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+6K121513Multix FusionSiemens Medical Solution2012324
+6K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+6K120697Eagle Eye Platinum ST CatheterVolcano Corporation201212—
+6K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+6K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+6K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+6K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+6K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+6K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+6K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+6K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+6K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+6K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+6K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+6K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+6K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+6K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+6K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+7K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+7K251417ReVISION 2Argus Cognitive, Inc.20260—
+7K260192DIANAROPCA ApS20260—
+7K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+7K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+7K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+7K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+7K250670EchoConfidence (USA)Mycardium AI Limited20250—
+7K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K242359Strain AI (SAI001)Exo, Inc.20240—
+7K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—
+7K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+7K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+7K232501AI Platform (AIP001)Exo, Inc.20231—
+7K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+7K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC20230—
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+7K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+7K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC20221—
+7K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+7K212376Caas QardiaPie Medical Imaging BV20220—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+7K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+7K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+7K212012Follicle ClarityCycle Clarity20221—
+7K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+7K213275EchoGo Core (2.0)Ultromics Limited20211—
+7K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+7K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+7K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+7K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+7K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+7K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+7K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+7K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+7K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+7K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+7K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+7K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+7K201990DC-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—
+7K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+7K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+7K200603AAA ModelPhilips Ultrasound, Inc.20200—
+7K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K2013523D Auto LAAPhilips Health Care20200—