510(k) Report

Devices descending from K003931

1,004 later devices reach Vivid 7 with Sonopac, Model FB0008XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K212100KosmosEchoNous, Inc.202101
+8K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+8K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+8K2116563D Echo v1.1Jointvue, LLC20210—
+8K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+8K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+8K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+8K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+8K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+8K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+8K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+8K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+8K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+8K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+8K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+8K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+8K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+8K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+8K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+8K191171EchoGo CoreUltromics, Ltd.20193—
+8K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+8K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+8K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+8K181783Logiq P9; Logiq P7GE Healthcare2018171
+8K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+8K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+8K180535Voluson P6 and Voluson P8GE Healthcare2018121
+8K172256SoftVueDelphinus Medical Technologies20180—
+8K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+8K173569Ultrasound System 1300Bk Medical Aps20181—
+8K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+8K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+8K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+8K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+8K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+8K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+8K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+8K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+8K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+8K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+8K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+8K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+8K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+8K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+8K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+8K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+8K150239FibroScanEchosens201525—
+8K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+8K150949FibroScanEchosens201542—
+8K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+8K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+8K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+8K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+8K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+8K142077MylabgammaEsaote, S.p.A.201453
+8K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+8K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+8K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+8K140808Q-StationPhilips Ultrasound, Inc.201402
+8K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+8K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+8K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+8K123806FibroscanEchosens201355—
+8K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+8K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+8K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+8K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+8K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+9K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K251417ReVISION 2Argus Cognitive, Inc.20260—
+9K260192DIANAROPCA ApS20260—
+9K253452Accuro 3SRivanna Medical, Inc.20260—
+9K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+9K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+9K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+9K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+9K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+9K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+9K254021Accuro XVRivanna Medical, Inc.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—