510(k) Report

Devices descending from K981505

233 later devices reach Cozumel Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc.1999196—
+1K990806C1 Ultrasound SystemSonosite,Inc.1999232—
+2K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+2K022153Bladderscan Bvi 6100Diagnostic Ultrasound Corp.2002471
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+3K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+3K121689Vitascan LT ScanmasterVitacon Medical, Inc.20120—
+3K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+3K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+3K071217Bladderscan Bvi 9400 UltrasoundVerathon Incorporated2007451
+3K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+3K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+3K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+3K030763Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemDiagnostic Ultrasound Corp.200341
+4K170046Lilium a-200ELilium Otsuka Co., Ltd.20170—
+4K160420SpeqTSignostics Limited20161—
+4K153101BladderScan Prime SystemVerathon Incorporated20154—
+4K152250SpeqRTSignostics Limited20150—
+4K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+4K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+4K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+4K130229Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd.20137—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+4K111021Cubescan / Biocon-700Mcube Technology Co., Ltd.201113—
+4K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+4K100745Lifebed Network Patient Vigilance SystemHoana Medical, Inc.20100—
+4K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+4K091518Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd.200916—
+4K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc.20092—
+4K090214Verathon Inc. Bladderscan BVM 9500 UltrasoundVerathon Incorporated200901
+4K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+4K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+4K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+5K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+5K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+5K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+5K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+5K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+5K191307Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd.20191—
+5K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+5K181574UscanEchoNous, Inc.20180—
+5K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+5K171594AccuroRivanna Medical, LLC20173—
+5K172356BladderScan Prime PLUS SystemVerathon Incorporated201731
+5K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd.20174—
+5K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+5K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+5K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+5K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+5K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+5K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+5K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K131227Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd.20137—
+5K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+5K113304Bladder ScannerMEDA Co., Ltd.20121—
+5K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+5K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+5K092037Lifegurney Network Patient Vigilance SystemHoana Medical, Inc.20090—
+5K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+5K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+6K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+6K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+6K243937Accuro 3SRivanna Medical, Inc.20252—
+6K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+6K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+6K231677EdgeFlow UH10Edgecare, Inc.20241—
+6K223448Bladder Scanner Model: BVT02Xuzhou Kaixin Electronic Instrument Co., Ltd.20230—
+6K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+6K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+6K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+6K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+6K210591Palm Bladder Scanner - PBSV7.1Mianyang Meike Electronic Equipment Co., Ltd.20210—
+6K200980Auto 3D Bladder Volume ToolButterfly Network, Inc.20200—
+6K200749CUBEScan BioCon-900SMcube Technology Co., Ltd.20200—
+6K200548CUBEScan BioCon-1100Mcube Technology Co., Ltd.20202—
+6K190769Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd.20193—
+6K182460MD-6000P Bladder ScannerMEDA Co., Ltd.20190—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+6K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+6K171528Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)Avantsonic Technology Co., Ltd.20180—
+6K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+6K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+6K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+6K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+6K153581Bladder ScannerCaresono Technology Co., Ltd.20160—
+6K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+6K152922ViziShot FLEXSpiration, Inc.20166—
+6K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+6K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+6K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+6K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—