510(k) Report

Devices descending from K041552

996 later devices reach GE Vivid 7 BT04 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+7K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+7K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+7K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+7K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+7K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+7K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+7K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K191171EchoGo CoreUltromics, Ltd.20193—
+7K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+7K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+7K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+7K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+7K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+7K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+7K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+7K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+7K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+7K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+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—
+7K171594AccuroRivanna Medical, LLC20173—
+7K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K1725133D EchoJointvue, LLC20171—
+7K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+7K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K170841BiopSee, Mobile USMedcom GmbH20170—
+7K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+7K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+7K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+7K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+7K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+7K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+7K161960bk2300Bk Medical Aps20165—
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+7K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+7K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+7K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+7K160162Voluson P6, Voluson P8GE Healthcare201613—
+7K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+7K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+7K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+7K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+7K150239FibroScanEchosens201525—
+7K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+7K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+7K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+7K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+7K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+7K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+7K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+7K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+7K142077MylabgammaEsaote, S.p.A.201453
+7K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+7K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+7K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+7K140808Q-StationPhilips Ultrasound, Inc.201402
+7K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+7K133277XARIO 100Toshibamedical Systems Corporation20142—
+7K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+7K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+7K123806FibroscanEchosens201355—
+7K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+7K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+7K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+7K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+7K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+8K251417ReVISION 2Argus Cognitive, Inc.20260—
+8K260192DIANAROPCA ApS20260—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+8K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+8K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+8K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+8K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+8K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—