510(k) Report

Devices descending from K891453

205 later devices reach Diagnostic Ultrasound Transducer: Pve-582V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964865PVK-720ST Endocavitary TransducerToshiba America Medical Systems, In.C1997204—
+2K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C1999203—
+3K051334Terason Ultrasound System with Continuous Wave SopplerTeratech Corp.20055—
+3K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc.1999196—
+4K082147Bodymetrix BX2000Intelametrix, Inc.20092—
+4K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+4K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+4K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+5K202514EchoS FamilyEcholight S.P.A20211—
+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—
+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—
+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—
+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—
+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
+7K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+7K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+7K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+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—
+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—
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+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—
+8K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+8K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+8K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+8K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+8K152922ViziShot FLEXSpiration, Inc.20166—
+8K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+8K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+8K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+8K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+8K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+8K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+8K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+9K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+9K250145Biopsy Port AdapterEndosound, Inc.20250—
+9K243937Accuro 3SRivanna Medical, Inc.20252—
+9K231267ClearTipFinemedix Co., Ltd.20231—
+9K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+9K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+9K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+9K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+9K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+9K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+9K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+9K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K193518KosmosEchoNous, Inc.20201—
+9K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+9K190669EndoticsEra Endoscopy S.R.L.20200—
+9K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+9K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+9K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+9K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+9K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+9K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+9K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—