510(k) Report

Devices descending from K030949

683 later devices reach Titan High Resolution Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+1K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056784
+1K043452Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc.200411—
+1K033367Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System…Sonosite,Inc.200313—
+2K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+2K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+2K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K080223Zura Tee SystemImacor, LLC20085831
+2K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+2K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+3K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+3K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+3K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+3K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+3K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+3K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+3K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+3K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+3K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+4K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+4K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+4K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+4K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+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—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+4K133533Logiq EGE Healthcare2014149—
+4K133431VENUE 50GE Healthcare201360—
+4K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+4K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+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—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+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—
+4K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+4K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+5K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+5K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+5K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+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—
+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—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+5K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K161960bk2300Bk Medical Aps20165—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+5K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+5K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+5K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+5K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+5K143601U-LiteSonoscanner Sarl20153—
+5K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—