510(k) Report

Devices descending from K020353

1,026 later devices reach Omnia X/XS Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071314Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20070—
+1K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+1K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056784
+1K043452Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc.200411—
+1K042833Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004928—
+1K040502Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004930—
+1K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004950—
+1K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20039551
+1K030949Titan High Resolution Ultrasound SystemSonosite,Inc.2003683—
+2K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+2K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+2K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+2K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K080223Zura Tee SystemImacor, LLC20085831
+2K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K070077Ultrasound Scanner Profocus, Model 2202B-K Medical Aps20070—
+2K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+2K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+2K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+2K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20059211
+2K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C20041961
+2K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927—
+2K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+2K042044Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20044291
+2K033367Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System…Sonosite,Inc.200313—
+3K160420SpeqTSignostics Limited20161—
+3K152250SpeqRTSignostics Limited20150—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.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
+3K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+3K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+3K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+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—
+3K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+3K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+3K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+3K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+3K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+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—
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+3K070515A-View Basic and PlusCordatec N.V.20071—
+3K070903MYLAB40Esaote Europe B.V.200727—
+3K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+3K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+3K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+3K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+3K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+3K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+3K060879Model EC9-4 TransducerSiemens Medical Solutions USA, Inc.20061—
+3K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+3K051500Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C2005195—
+3K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+4K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+4K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+4K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+4K181574UscanEchoNous, Inc.20180—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170338A-ViewStroke2prevent B.V.20170—
+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—
+4K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+4K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+4K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+4K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+4K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+4K133533Logiq EGE Healthcare2014149—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K133431VENUE 50GE Healthcare201360—
+4K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+4K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+4K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+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—