510(k) Report

Devices descending from K010329

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K220851VenueGE Medical Systems20223—
+8K220848Venue FitGE Medical Systems202241
+8K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+8K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+8K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+8K211527Exo IrisExo Imaging, Inc.20211—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+8K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+8K2116563D Echo v1.1Jointvue, LLC20210—
+8K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+8K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+8K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+8K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K201988T-LiteSonoscanner20201—
+8K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+8K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+8K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+8K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+8K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+8K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+8K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+8K193518KosmosEchoNous, Inc.20201—
+8K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+8K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+8K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+8K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+8K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+8K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+8K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+8K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+8K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+8K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+8K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+8K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+8K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+8K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+8K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+8K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+8K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+8K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+8K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K160162Voluson P6, Voluson P8GE Healthcare201613—
+8K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+8K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+8K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+8K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+8K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+8K133277XARIO 100Toshibamedical Systems Corporation20142—
+9K253452Accuro 3SRivanna Medical, Inc.20260—
+9K254021Accuro XVRivanna Medical, Inc.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+9K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+9K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+9K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+9K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+9K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+9K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+9K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+9K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+9K232285U-Lite PROSonoscanner Sarl20240—
+9K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+9K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+9K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+9K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+9K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+9K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+9K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+9K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+9K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+9K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—