510(k) Report

Devices descending from K921148

1,094 later devices reach Cvis Insight Catheters for Intracardiac Use through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992631Acunav Diagnostic Ultrasound CatheterAcuson Corp.19991,0931
+2K162789Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc.20170—
+2K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+2K063076Reprocessed Diagnostic Ultrasound CatheterAscent Healthcare Solutions20070—
+2K070011Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging CatheterIrvine Biomedical,Inc.(Ibi)20070—
+2K033436Reprocessed Diagnostic Ultrasound CatheterAlliance Medical Corp.20050—
+2K043453Sterilemed Reprocessed Ivus Imaging CatheterSterilmed, Inc.200503
+2K042593Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc.2004930—
+2K033650Acunav 90/10 Diagnostic Ultrasound CatheterSiemens Medical Solutions USA, Inc.20049451
+2K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.20021,069—
+3K110076Reprocessed 3D Diagnostic Ultrasound CatheterSterilmed, Inc.201111
+3K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+3K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+3K100363Ultra Dci Model 5000Ultrasound Medical Devices, Inc.20100—
+3K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+3K070242Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc.200714—
+3K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+3K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+3K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+3K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+3K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184—
+3K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+3K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20031,003—
+3K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20039551
+4K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+4K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…Sterilmed, Inc.20160—
+4K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+4K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+4K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc.20115—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+4K103761Visualize: VascularThe Medipattern Corporation20110—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+4K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+4K091352Soundstar 3D Diagnostic Catheter, Model M-5723-05Biosense Webster, Inc.20091—
+4K092425Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10Ascent Healthcare Solutions20090—
+4K092064Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc.20099—
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+4K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+4K082135ShowcaseTrillium Technology, Inc.20080—
+4K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+4K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+4K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+4K070903MYLAB40Esaote Europe B.V.200727—
+4K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+4K070077Ultrasound Scanner Profocus, Model 2202B-K Medical Aps20070—
+4K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+4K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+4K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+4K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+4K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+4K042044Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20044291
+4K041581Compacs, Version 1.0Intelligent Images Srl20041—
+4K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+4K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004988—
+4K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004950—
+5K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+5K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+5K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…Surgical Instrument Service and Savings, Inc.20250Class I
+5K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc.20241—
+5K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.20231—
+5K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+5K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC20170—
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+5K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+5K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+5K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+5K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+5K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K140677MylabssognoEsaote, S.p.A.20140—
+5K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+5K140254EZONO 4000Ezono AG201413—
+5K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+5K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+5K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+5K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+5K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—