510(k) Report

Devices descending from K023720

896 later devices reach Sonoline Antares Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080930Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc.200831
+1K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+1K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+1K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc.200564—
+1K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20046774
+2K141870Breast Volume NavigatorMetritrack, LLC20142—
+2K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+2K092067Abvs WorkplaceSiemens AG Medical Solutions20092—
+2K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K082543Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100Sonocine, Inc.20082—
+2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation200853—
+2K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K070477Orison Embrace SystemOrison Corporation20073—
+2K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+3K260190ArthurROPCA ApS20260—
+3K213620ATUSA™ Automated 3D Breast Ultrasound SystemIsono Health, Inc.20220—
+3K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+3K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+3K161354MELODY, Remote Control System for Ultrasound ProbeAdecho Tech20171—
+3K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+3K151075BR-ABVS Viewer 1.0Taihao Medical, Inc.20161—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+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—
+3K123209SoftvueDelphinus Medical Technologies, Inc.201350—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+3K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+3K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+3K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+3K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+3K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+3K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+3K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+3K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+3K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+3K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+3K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+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—
+4K180641Invenia ABUS ViewerGE Healthcare20180—
+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
+4K142100AixplorerSupersonic Imagine201463—
+4K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+4K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+4K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+4K133533Logiq EGE Healthcare2014149—
+4K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+4K133431VENUE 50GE Healthcare201360—
+4K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+4K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+4K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+4K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+4K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+4K132171AixplorerSupersonic Imagine201364—
+4K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+4K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+4K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+4K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K121329AixplorerSupersonic Imagine2012405—
+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—
+4K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+4K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+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—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+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—
+4K102041AixplorerSupersonic Imagine2010527—
+4K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+4K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+4K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882