510(k) Report

Devices descending from K961459

1,077 later devices reach Level 10 Hdi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+4K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K121329AixplorerSupersonic Imagine2012405—
+4K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+4K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+4K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd.2010104—
+4K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+4K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+4K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+4K093714Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2009111—
+4K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+4K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2009123—
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+4K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+4K082147Bodymetrix BX2000Intelametrix, Inc.20092—
+4K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+4K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+4K081676Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd.2008105—
+4K080800Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2008124—
+4K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2007125—
+4K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+4K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+4K053530Sonoace X4 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+4K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+4K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+4K043588Mylab 15 / Mylab 20, Model 2700Pie Medical200530—
+4K040926Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC20040—
+4K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+5K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+5K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+5K202514EchoS FamilyEcholight S.P.A20211—
+5K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+5K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+5K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+5K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+5K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+5K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+5K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+5K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+5K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+5K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+5K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+5K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+5K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+5K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+5K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+5K171594AccuroRivanna Medical, LLC20173—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K163443Interson USB Ultrasound SystemInterson Corporation20173—
+5K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K161999AixplorerSupersonic Imagine201620—