510(k) Report

Devices descending from K994096

196 later devices reach Sonoheart Hand-Carried Echocardiography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+1K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+2K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+2K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+2K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+2K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+2K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+2K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+3K160420SpeqTSignostics Limited20161—
+3K152250SpeqRTSignostics Limited20150—
+3K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+3K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+3K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+3K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+3K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+3K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+4K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+4K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+4K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+4K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+4K181574UscanEchoNous, Inc.20180—
+4K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+4K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+4K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+4K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+4K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+4K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+4K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+4K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+4K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+4K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+5K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+5K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+5K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+5K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+5K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+5K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+5K171594AccuroRivanna Medical, LLC20173—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+5K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+5K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+5K152922ViziShot FLEXSpiration, Inc.20166—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+5K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+5K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+6K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+6K250145Biopsy Port AdapterEndosound, Inc.20250—
+6K243937Accuro 3SRivanna Medical, Inc.20252—
+6K231267ClearTipFinemedix Co., Ltd.20231—
+6K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+6K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+6K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+6K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+6K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K200708Vivid iqGe Medical Systems Ultrasound And20203—
+6K193518KosmosEchoNous, Inc.20201—
+6K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+6K190669EndoticsEra Endoscopy S.R.L.20200—
+6K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+6K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+6K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K163443Interson USB Ultrasound SystemInterson Corporation20173—
+6K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+6K162549Lumify Ultrasound SystemPhilips Health Care2016436
+6K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—