510(k) Report

Devices descending from K052441

629 later devices reach GE Logiq 7 Ultrasound BT05 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+5K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+5K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+5K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+5K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+5K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+5K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+5K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+5K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+5K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+5K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+5K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K141675Voluson P6, Voluson P8GE Healthcare201414—
+5K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+5K140254EZONO 4000Ezono AG201413—
+5K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+5K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+5K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+5K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+5K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+5K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+5K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+5K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+5K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+5K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+5K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+5K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+6K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+6K243937Accuro 3SRivanna Medical, Inc.20252—
+6K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+6K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+6K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+6K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+6K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+6K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+6K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+6K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+6K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+6K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+6K220851VenueGE Medical Systems20223—
+6K220848Venue FitGE Medical Systems202241
+6K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+6K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+6K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+6K211527Exo IrisExo Imaging, Inc.20211—
+6K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+6K2116563D Echo v1.1Jointvue, LLC20210—
+6K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+6K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K201988T-LiteSonoscanner20201—
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K200655FibroScan® 630Echosens20200—
+6K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+6K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+6K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+6K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+6K193518KosmosEchoNous, Inc.20201—
+6K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+6K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+6K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+6K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+6K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+6K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+6K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+6K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+6K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+6K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+6K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+6K170841BiopSee, Mobile USMedcom GmbH20170—