510(k) Report

Devices descending from K053069

676 later devices reach Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+1K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+1K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+1K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+1K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+1K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+1K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+1K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+1K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+1K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+1K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+1K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+1K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+2K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+2K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+2K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+2K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+2K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+2K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+2K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+2K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+2K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+2K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+2K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+2K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+2K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+2K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+2K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+2K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+2K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+2K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+2K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+2K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+2K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+2K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+2K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+2K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+2K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+2K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+2K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+2K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+2K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+2K083421MR-Touch OptionGe Medical Systems, LLC20094—
+3K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+3K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+3K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+3K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+3K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+3K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+3K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+3K161960bk2300Bk Medical Aps20165—
+3K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+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—
+3K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+3K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+3K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+3K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+3K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+3K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+3K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+3K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+3K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+3K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+3K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+3K133533Logiq EGE Healthcare2014149—
+3K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+3K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+3K133431VENUE 50GE Healthcare201360—
+3K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+3K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+3K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+3K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+3K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+3K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+3K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+3K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+3K111582Logiq S8GE Healthcare20113673
+3K110943Logiq E9GE Healthcare20114722
+3K103649Voluson S6, Voluson S8GE Healthcare2011296—
+3K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+3K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+3K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+4K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+4K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+4K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+4K200655FibroScan® 630Echosens20200—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—