510(k) Report

Devices descending from K010329

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+5K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+5K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+5K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+5K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+5K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+5K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K152195Logiq S8GE Healthcare201557—
+5K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+5K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+5K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+5K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+5K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+5K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+5K140254EZONO 4000Ezono AG201413—
+5K133533Logiq EGE Healthcare2014149—
+5K133034Logiq F SeriesGE Healthcare2014155—
+5K133431VENUE 50GE Healthcare201360—
+5K132687E-CUBE 7Alpinion Medical Systems Co., Ltd.201316—
+5K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+5K131937Voluson I/EGE Healthcare201335—
+5K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+5K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+5K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+5K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+5K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+5K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+5K1311184D VIEWGE Healthcare20131—
+5K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+5K123610E-CUBE 15Alpinion Medical Systems Co., Ltd.20131—
+5K123611E-CUBE 7Alpinion Medical Systems Co., Ltd.20120—
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+5K121729E-CUBE 7Alpinion Medical Systems Co., Ltd.20120—
+5K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+5K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+5K121888E-CUBE 15Alpinion Medical Systems Co., Ltd.20120—
+5K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+5K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+5K120741Voluson S6, Voluson S8GE Healthcare2012295—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+5K112371Logiq P3GE Healthcare20110—
+5K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+5K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+5K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+5K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+5K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+5K083421MR-Touch OptionGe Medical Systems, LLC20094—
+6K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+6K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+6K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+6K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+6K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+6K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+6K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+6K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+6K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+6K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+6K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—