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
+5K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+5K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K161999AixplorerSupersonic Imagine201620—
+5K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+5K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+5K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+5K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+5K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+5K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+5K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+5K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+5K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+5K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+5K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+5K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+5K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+5K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+5K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+5K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+5K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+5K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+5K140677MylabssognoEsaote, S.p.A.20140—
+5K133533Logiq EGE Healthcare2014149—
+5K133431VENUE 50GE Healthcare201360—
+5K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+5K132274AixplorerSupersonic Imagine2013312—
+5K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+5K130779Lvivo EF SystemDiacardio, Ltd.201324—
+5K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+5K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+5K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+5K120282CardnavPaieon, Inc.20120—
+5K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+5K111142Echosoft (TM)Echometrix, LLC20120—
+5K112255AixplorerSupersonic Imagine2012525—
+5K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+5K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+5K121384MylabsognoEsaote, S.p.A.201211
+5K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+5K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+5K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+5K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+5K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+5K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+5K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+5K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+5K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+5K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+5K110688MylabgoldEsaote2011251
+5K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+5K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+5K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+5K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+5K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+5K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+5K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+5K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+5K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+5K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+5K083421MR-Touch OptionGe Medical Systems, LLC20094—
+5K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+6K260748ES-SeriesE-Scopics20260—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+6K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+6K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+6K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—