510(k) Report

Devices descending from K011224

691 later devices reach Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+1K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+1K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+1K053648Pioneer TC8080, Companion IiiViasys Neuro Care20064—
+1K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+1K052109Sonosite Hand-Carried Ultrasound System (C1 Series)Sonosite,Inc.20050—
+1K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056784
+1K043452Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc.200411—
+1K030949Titan High Resolution Ultrasound SystemSonosite,Inc.2003683—
+1K023957Sonosite Hand-Carried Ultrasound System (C2 Series)Sonosite,Inc.20020—
+2K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+2K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+2K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+2K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+2K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+2K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+2K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+2K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+2K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+2K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+2K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+2K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+2K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+2K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+2K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+2K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+2K080223Zura Tee SystemImacor, LLC20085831
+2K060421Sonara; Sonara/TekViasys Healthcare, Inc.200632
+2K033367Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System…Sonosite,Inc.200313—
+3K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+3K170859Dolphin/IQ and Dolphin/4DViasonix, Ltd.20172—
+3K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+3K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+3K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+3K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+3K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+3K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+3K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+3K133533Logiq EGE Healthcare2014149—
+3K133431VENUE 50GE Healthcare201360—
+3K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+3K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+3K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+3K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+3K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+3K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+3K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+3K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+3K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+3K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+3K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+3K083421MR-Touch OptionGe Medical Systems, LLC20094—
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+4K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+4K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd.20191—
+4K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+4K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+4K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+4K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+4K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K161960bk2300Bk Medical Aps20165—
+4K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+4K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+4K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+4K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+4K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+4K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+4K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+4K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+4K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+4K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+4K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+4K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—