510(k) Report

Devices descending from K082185

627 later devices reach GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+1K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+1K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+1K090754LipocontrolOsyris Medical20110—
+1K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+1K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+1K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+1K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K201768Voluson E10GE Healthcare20204—
+2K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+2K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+2K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+2K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+2K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+2K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+2K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+2K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+2K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+2K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+2K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+2K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+2K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+2K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+2K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+2K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+2K111142Echosoft (TM)Echometrix, LLC20120—
+2K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+2K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+2K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+2K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+2K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+2K111582Logiq S8GE Healthcare20113673
+2K110943Logiq E9GE Healthcare20114722
+2K103649Voluson S6, Voluson S8GE Healthcare2011296—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+2K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+2K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+2K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+3K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+3K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+3K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+3K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+3K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+3K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+3K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+3K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+3K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+3K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+3K163119NaviSuite SSI EditionMedcom GmbH20171—
+3K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+3K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+3K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+3K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+3K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+3K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+3K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+3K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+3K140254EZONO 4000Ezono AG201413—
+3K131527Logiq S8GE Healthcare2013219—
+3K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+3K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+3K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+3K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+3K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+3K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+3K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+3K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+3K120741Voluson S6, Voluson S8GE Healthcare2012295—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+4K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+4K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+4K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+4K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+4K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+4K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+4K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+4K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+4K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—