510(k) Report

Devices descending from K003125

951 later devices reach Sonoline Elegra Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+7K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+7K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+7K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+7K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+7K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K181637DC-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—
+7K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+7K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+7K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+7K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+7K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+7K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+7K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+7K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+7K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+7K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+7K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+7K163119NaviSuite SSI EditionMedcom GmbH20171—
+7K170069AmCAD-UVAmcad Biomed Corporation20170—
+7K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+7K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+7K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+7K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+7K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+7K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+7K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+7K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+7K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+7K150239FibroScanEchosens201525—
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+7K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+7K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+7K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+7K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+7K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+7K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+7K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+7K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+7K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+7K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+7K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+7K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+7K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+7K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+7K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+7K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+7K140808Q-StationPhilips Ultrasound, Inc.201402
+7K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+7K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+7K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+7K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+7K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+7K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+7K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+7K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+7K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+7K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+7K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+7K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+7K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+7K123806FibroscanEchosens201355—
+7K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+7K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+7K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+7K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+7K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+7K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+7K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—