510(k) Report

Devices descending from K944004

654 later devices reach Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150442Volcano Visions PV .018 Digital IVUS CatheterVolcano Corporation201551
+1K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+1K061215Volcano S51 Family of Imaging SystemsVolcano Corporation2006613—
+1K051920Volcano S5 Imaging System, Model 804200-001Volcano Corporation20056141
+1K031148IN-Vision Imaging SystemJomed, Inc.2003648—
+2K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device20250—
+2K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc.20250—
+2K230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLC20230—
+2K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation20201—
+2K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+2K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+2K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+2K060483Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation200631—
+2K052348IN Vision Gold with Spin Vision, Model 891 SVVolcano Corporation200529—
+3K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+3K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+3K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+3K151780CAAS WorkstationPie Medical Imaging BV20169—
+3K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+3K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+3K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+3K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+3K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+3K083421MR-Touch OptionGe Medical Systems, LLC20094—
+3K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+4K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+4K180019CAAS WorkstationPie Medical Imaging BV20188—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+4K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+4K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+4K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+4K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+4K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+4K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+4K111582Logiq S8GE Healthcare20113673
+4K110943Logiq E9GE Healthcare20114722
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K103649Voluson S6, Voluson S8GE Healthcare2011296—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+4K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+4K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+4K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+4K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+5K251355X1-FFRSpectrawave, Inc.20250—
+5K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+5K232147CAAS WorkstationPie Medical Imaging BV20241—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K133323Volcano Ifr ModalityVolcano Corporation201418—
+5K133142Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…Volcano Corporation20130—
+5K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+5K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation20130—
+5K131527Logiq S8GE Healthcare2013219—
+5K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+5K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation20131—
+5K120282CardnavPaieon, Inc.20120—
+5K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+5K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+5K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+5K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+5K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+5K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+5K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+5K120741Voluson S6, Voluson S8GE Healthcare2012295—
+5K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+5K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K113076Caas a-ValvePie Medical Imaging BV20121—
+5K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+5K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+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—
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+6K243769QFR (3.0)Qfr Solutions BV20250—
+6K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+6K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+6K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+6K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+6K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—