510(k) Report

Devices descending from K061215

613 later devices reach Volcano S51 Family of Imaging Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+1K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+1K082135ShowcaseTrillium Technology, Inc.20080—
+1K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+2K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+2K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+2K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+2K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+2K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+2K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+2K083421MR-Touch OptionGe Medical Systems, LLC20094—
+2K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+3K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+3K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+3K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+3K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+3K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+3K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+3K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+3K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+3K111582Logiq S8GE Healthcare20113673
+3K110943Logiq E9GE Healthcare20114722
+3K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+3K103649Voluson S6, Voluson S8GE Healthcare2011296—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+3K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+4K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+4K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+4K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+4K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+4K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+4K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+4K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+4K131527Logiq S8GE Healthcare2013219—
+4K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+4K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+4K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+4K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+4K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+4K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+4K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+4K120741Voluson S6, Voluson S8GE Healthcare2012295—
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+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—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+5K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+5K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K161999AixplorerSupersonic Imagine201620—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+5K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+5K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+5K160357TrinityKoelis20161—
+5K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+5K160182LOGIQ S7 ExpertGE Healthcare2016361
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+5K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K152195Logiq S8GE Healthcare201557—
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+5K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+5K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+5K143452Logiq P9, Logiq P7GE Healthcare2015131—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K141639Voluson S6, Voluson S8GE Healthcare2014151—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+5K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—