510(k) Report

Devices descending from K081921

579 later devices reach GE Vivid E9 Ultrasound through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20122531
+1K101149GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS2010350—
+1K101324GE Echopac Model BT10Ge Vingmed Ultrasound AS2010172—
+1K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+2K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+2K131527Logiq S8GE Healthcare2013219—
+2K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+2K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+2K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+2K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+2K121063Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121762
+2K121062Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121101
+2K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+2K120221GE EchopacGE Healthcare2012170—
+2K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+2K111582Logiq S8GE Healthcare20113673
+2K110943Logiq E9GE Healthcare20114722
+2K103649Voluson S6, Voluson S8GE Healthcare2011296—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+2K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+3K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+3K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+3K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+3K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+3K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+3K152195Logiq S8GE Healthcare201557—
+3K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+3K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+3K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+3K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+3K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+3K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+3K141639Voluson S6, Voluson S8GE Healthcare2014151—
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+3K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+3K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+3K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+3K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K133533Logiq EGE Healthcare2014149—
+3K133034Logiq F SeriesGE Healthcare2014155—
+3K133431VENUE 50GE Healthcare201360—
+3K123894GE EchopacGe Vingmed Ultrasound AS20139—
+3K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+3K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+3K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+3K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+3K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+3K120741Voluson S6, Voluson S8GE Healthcare2012295—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K250955XC11 ICE System, USAYorlabs, Inc.20250—
+4K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+4K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+4K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+4K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+4K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+4K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+4K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+4K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+4K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+4K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+4K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+4K170445Logiq S8GE Healthcare2017191
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+4K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+4K161999AixplorerSupersonic Imagine201620—
+4K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+4K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+4K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+4K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+4K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—