510(k) Report

Devices descending from K073408

628 later devices reach GE Logiq BT08 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia20086271
+2K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+2K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+2K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+2K090754LipocontrolOsyris Medical20110—
+2K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+2K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+2K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+3K201768Voluson E10GE Healthcare20204—
+3K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+3K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+3K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+3K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+3K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+3K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+3K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+3K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+3K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+3K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+3K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+3K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+3K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+3K111142Echosoft (TM)Echometrix, LLC20120—
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+3K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+3K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+3K111582Logiq S8GE Healthcare20113673
+3K110943Logiq E9GE Healthcare20114722
+3K103649Voluson S6, Voluson S8GE Healthcare2011296—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+3K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+3K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+3K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+4K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+4K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+4K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+4K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+4K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+4K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+4K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+4K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+4K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+4K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+4K140254EZONO 4000Ezono AG201413—
+4K131527Logiq S8GE Healthcare2013219—
+4K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+4K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+4K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+4K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+4K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+4K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+4K120741Voluson S6, Voluson S8GE Healthcare2012295—
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+4K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+5K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+5K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+5K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+5K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—