510(k) Report

Devices descending from K010329

717 later devices reach LOGIQ 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia2007628—
+1K052042Sonoscape Ssi-1000/Ssi-5000 Ultrasound TransducersSonoscape Company Limited200533—
+1K042369Sonoscape Ultrasound System Ssi-1000/Ssi-5000Sonoscape Company Limited200440—
+1K041813GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia2004630—
+1K032182GE Logiq 7, Model 2354858General Electric Co.2003631—
+1K014097GE Logiq 5GE Medical Systems20026571
+2K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+2K102989Opus Diagnostic Ultrasound System & TransducersChang Gung Medical Technology Co., Ltd. Linkou Fac20104—
+2K101337A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20101—
+2K091877Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array…Chison Medical Imaging Co., Ltd.20090—
+2K090229Diagnostic Doppler Ultrasound System 2-5MHZ Curved Linear Array, 5-10MHZ Linear Array…Chang Gung Medical Supplies & Equipment Corp.20090—
+2K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia20086271
+2K052441GE Logiq 7 Ultrasound BT05General Electric Co.2005629—
+2K032974GE Logiq 5 Pro or ExpertGeneral Electric Co.2003654—
+2K020263LOGIQ 3General Electric Co.200211
+3K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+3K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+3K132690UP600 Diagnostic Doppler Ultrasound SystemQisda Corporation20143—
+3K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+3K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+3K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+3K111582Logiq S8GE Healthcare20113673
+3K110943Logiq E9GE Healthcare20114722
+3K090754LipocontrolOsyris Medical20110—
+3K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+3K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+3K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+3K072075Modification to GE Logiq A3General Electric Co.20070—
+3K060993GE Logiq P5 and A5General Electric Co.2006653—
+4K201768Voluson E10GE Healthcare20204—
+4K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+4K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+4K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+4K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+4K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+4K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+4K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+4K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+4K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+4K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+4K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+4K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+4K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+4K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+4K131527Logiq S8GE Healthcare2013219—
+4K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+4K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+4K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+4K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+4K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+4K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+4K111142Echosoft (TM)Echometrix, LLC20120—
+4K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+4K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+4K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+4K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K120060E-CUBE 9Alpinion Medical Systems Co., Ltd.201223—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+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—
+4K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+4K112122VENUE 40GE Healthcare2011160—
+4K111864E-CUBE 9Alpinion Medical Systems Co., Ltd.20110—
+4K103649Voluson S6, Voluson S8GE Healthcare2011296—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+4K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+4K102104GE Vivid P3 Diagnostic Ultrasound Imaging SystemWipro GE Healthcare Private, Ltd.20101—
+4K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+4K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+4K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+4K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+4K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+4K073297GE Logiq P6General Electric Co.20072242
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+5K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+5K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+5K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+5K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+5K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+5K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+5K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—