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
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+6K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+6K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+6K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+6K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+6K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+6K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+6K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+6K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+6K172256SoftVueDelphinus Medical Technologies20180—
+6K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+6K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+6K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+6K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+6K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+6K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+6K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+6K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+6K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+6K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K170069AmCAD-UVAmcad Biomed Corporation20170—
+6K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+6K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+6K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+6K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+6K161960bk2300Bk Medical Aps20165—
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+6K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+6K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+6K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+6K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+6K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+6K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+6K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+6K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+6K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+6K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+6K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+6K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+6K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+6K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+6K150239FibroScanEchosens201525—
+6K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+6K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+6K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+6K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+6K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+6K150949FibroScanEchosens201542—
+6K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+6K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+6K143601U-LiteSonoscanner Sarl20153—
+6K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+6K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+6K143452Logiq P9, Logiq P7GE Healthcare2015131—
+6K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+6K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+6K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+6K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+6K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+6K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+6K142077MylabgammaEsaote, S.p.A.201453
+6K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+6K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+6K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+6K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+6K140808Q-StationPhilips Ultrasound, Inc.201402
+6K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—