510(k) Report

Devices descending from K992631

1,093 later devices reach Acunav Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162789Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc.20170—
+1K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+1K063076Reprocessed Diagnostic Ultrasound CatheterAscent Healthcare Solutions20070—
+1K070011Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging CatheterIrvine Biomedical,Inc.(Ibi)20070—
+1K033436Reprocessed Diagnostic Ultrasound CatheterAlliance Medical Corp.20050—
+1K043453Sterilemed Reprocessed Ivus Imaging CatheterSterilmed, Inc.200503
+1K042593Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc.2004930—
+1K033650Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc.20049451
+1K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.20021,069—
+2K110076Reprocessed 3D Diagnostic Ultrasound CatheterSterilmed, Inc.201111
+2K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+2K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+2K100363Ultra Dci Model 5000Ultrasound Medical Devices, Inc.20100—
+2K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+2K070242Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc.200714—
+2K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+2K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+2K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+2K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+2K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184—
+2K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+2K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20031,003—
+2K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20039551
+3K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+3K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…Sterilmed, Inc.20160—
+3K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+3K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+3K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+3K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc.20115—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+3K103761Visualize: VascularThe Medipattern Corporation20110—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K091352Soundstar 3D Diagnostic Catheter, Model M-5723-05Biosense Webster, Inc.20091—
+3K092425Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10Ascent Healthcare Solutions20090—
+3K092064Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc.20099—
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+3K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+3K082135ShowcaseTrillium Technology, Inc.20080—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+3K070903MYLAB40Esaote Europe B.V.200727—
+3K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+3K070077Ultrasound Scanner Profocus, Model 2202B-K Medical Aps20070—
+3K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+3K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+3K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+3K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+3K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+3K042044Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20044291
+3K041581Compacs, Version 1.0Intelligent Images Srl20041—
+3K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+3K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004988—
+3K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004950—
+4K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+4K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+4K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc.20250Class I
+4K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc.20241—
+4K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20231—
+4K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+4K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+4K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+4K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC20170—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+4K140254EZONO 4000Ezono AG201413—
+4K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+4K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+4K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+4K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+4K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+4K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—