510(k) Report

Devices descending from K001400

982 later devices reach Elegra Millennium Enhanced Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20059211
+1K023720Sonoline Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.20028961
+2K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+2K080930Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc.200831
+2K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+2K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+2K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+2K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+2K060879Model EC9-4 TransducerSiemens Medical Solutions USA, Inc.20061—
+2K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+2K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc.200564—
+2K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20046774
+3K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+3K141870Breast Volume NavigatorMetritrack, LLC20142—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+3K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+3K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+3K093706Proxiscan Model 101Hybridyne Imaging Technologies, Inc.20100—
+3K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.200999—
+3K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+3K092067Abvs WorkplaceSiemens AG Medical Solutions20092—
+3K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+3K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+3K082135ShowcaseTrillium Technology, Inc.20080—
+3K082543Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100Sonocine, Inc.20082—
+3K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+3K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation200853—
+3K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2008278—
+3K072676Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc.20072795
+3K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+3K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2007427—
+3K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+3K070477Orison Embrace SystemOrison Corporation20073—
+3K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+4K260190ArthurROPCA ApS20260—
+4K213620ATUSA™ Automated 3D Breast Ultrasound SystemIsono Health, Inc.20220—
+4K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+4K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+4K161354MELODY, Remote Control System for Ultrasound ProbeAdecho Tech20171—
+4K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+4K151075BR-ABVS Viewer 1.0Taihao Medical, Inc.20161—
+4K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+4K142100AixplorerSupersonic Imagine201463—
+4K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+4K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+4K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+4K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+4K123209SoftvueDelphinus Medical Technologies, Inc.201350—
+4K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+4K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+4K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+4K132171AixplorerSupersonic Imagine201364—
+4K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+4K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+4K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K121329AixplorerSupersonic Imagine2012405—
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+4K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+4K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+4K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+4K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+4K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+4K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+4K102041AixplorerSupersonic Imagine2010527—
+4K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+4K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+4K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+4K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+4K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+4K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+4K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+4K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+4K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+4K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+4K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+4K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+4K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+4K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+5K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+5K180641Invenia ABUS ViewerGE Healthcare20180—
+5K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—