510(k) Report

Devices descending from K961459

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K081110Siui CTS-900 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments20080—
+3K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+3K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+3K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2006129—
+3K061153Gynesonics EC6 TransducerGynesonics, Inc.20067—
+3K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd.2006114—
+3K060087Accuvix V7 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+3K052911Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd.2005131—
+3K051334Terason Ultrasound System with Continuous Wave SopplerTeratech Corp.20055—
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+3K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd.2004182—
+3K032333Cryocare CS Surgical SystemEndocare, Inc.200313—
+3K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc.2003132—
+3K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc.20031845
+3K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+3K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+3K012887SA6000II Diagnostic Ultrasound SystemMedison America, Inc.200132—
+3K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc.1999196—
+3K992761Sonoace 5500 Diagnostic Ultrasound SystemMedison America, Inc.199933—
+4K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+4K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+4K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+4K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+4K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+4K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+4K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+4K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+4K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+4K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+4K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+4K181574UscanEchoNous, Inc.20180—
+4K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+4K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+4K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+4K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K163020Xperius Ultrasound SystemPhilips Health Care201611
+4K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+4K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+4K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+4K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+4K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+4K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+4K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+4K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+4K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+4K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+4K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+4K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+4K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+4K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+4K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+4K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+4K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+4K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+4K133533Logiq EGE Healthcare2014149—
+4K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+4K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+4K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201398—
+4K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+4K133431VENUE 50GE Healthcare201360—
+4K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+4K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+4K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+4K132171AixplorerSupersonic Imagine201364—
+4K132274AixplorerSupersonic Imagine2013312—
+4K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+4K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+4K123806FibroscanEchosens201355—
+4K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+4K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—