510(k) Report

Devices descending from K963315

405 later devices reach Vingmed Sound Color Flow Mapping System. System Five through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991842System Five/Echopac with Strain Rate ImagingGe Vingmed Ultrasound1999210—
+1K981397Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System…Toshiba America Medical Systems, In.C1998403—
+2K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+2K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C1999212—
+2K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C1999203—
+3K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+3K051334Terason Ultrasound System with Continuous Wave SopplerTeratech Corp.20055—
+3K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+3K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+3K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc.1999196—
+4K082147Bodymetrix BX2000Intelametrix, Inc.20092—
+4K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+4K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+4K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+4K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+4K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+4K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+4K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+4K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+5K202514EchoS FamilyEcholight S.P.A20211—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+5K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+5K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+5K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+5K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+5K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+5K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+5K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+5K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+5K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K160420SpeqTSignostics Limited20161—
+6K152250SpeqRTSignostics Limited20150—
+6K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+6K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+6K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+6K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+6K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+6K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+6K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+6K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+6K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+6K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+6K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+6K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+7K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+7K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+7K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+7K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+7K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+7K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+7K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+7K181574UscanEchoNous, Inc.20180—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+7K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+7K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+7K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+7K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+7K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+7K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+7K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+7K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+7K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+7K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+7K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+7K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+7K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+7K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+7K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+7K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+7K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+7K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+8K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+8K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+8K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+8K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+8K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+8K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+8K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+8K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+8K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+8K171594AccuroRivanna Medical, LLC20173—
+8K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+8K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+8K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—