510(k) Report

Devices descending from K926514

195 later devices reach Endoscopic Ultrasound System Type 20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseOlympus America, Inc.1998142—
+1K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Olympus Optical, Co.199867—
+1K971660Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Olympus America, Inc.1997752
+1K963023Ultrasound Gastroscope GF Type UM30POlympus America, Inc.199788—
+1K961048Olympus MH-246R Balloon SheathOlympus America, Inc.19965—
+1K951994Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc.1996148—
+2K231889Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic…Ultrasound Biotechnology (Shanghai) Co., Ltd.20230—
+2K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+2K100899Olympus Endoscopic Flushing Pump, Model Opf-2Keymed (Medical & Industrial Equipment), Ltd.201013
+2K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+2K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+2K051541GF-UE160-AL5 Ultrasound EndoscopeOlympus America, Inc.2005272
+2K042438Superdimension/BronchusSuperdimension, Ltd.2004731
+2K021204Olympus BF Type UM40Olympus Optical Co., Ltd.200244—
+2K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.2001601
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+2K994103Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Olympus America, Inc.20003—
+2K994106Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial UseOlympus America, Inc.20000—
+2K994069Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary UseOlympus America, Inc.20000—
+2K994373Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer…Atl Ultrasound, Inc.200027—
+2K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co.19981—
+2K982725Olympus MH-246R Balloon Sheath, for Female Reproductive Tract UseOlympus America, Inc.19980—
+2K982734Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co.19981—
+3K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20251—
+3K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.20250—
+3K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)FUJIFILM Healthcare Americas Corporation20232—
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K090095Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20097—
+3K080581VB Image ViewerOlympus Medical Systems Corporation20082—
+3K070515A-View Basic and PlusCordatec N.V.20071—
+3K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.200781
+3K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+3K052260Superdimension/Bronchus 4.1Superdimension, Ltd.2005562
+3K051585F-400 SystemMauna Kea Technologies200513—
+3K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation200416—
+3K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+3K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+3K030191Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp.200324—
+4K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20260—
+4K260009LungPoint Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Medical, Inc.20260—
+4K250883Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation20250—
+4K250762Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)Olympus Medical Systems Corporation20250—
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K170338A-ViewStroke2prevent B.V.20170—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+4K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+4K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies20147—
+4K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+4K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc.201241
+4K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+4K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc.201112—
+4K111243Fujinon Ultrasonic ProcessorFujinon, Inc.20117—
+4K093810BF-NaviKgt, Inc.20101—
+4K091160Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20095—
+4K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+4K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+4K061153Gynesonics EC6 TransducerGynesonics, Inc.20067—
+4K052852Superdimension/Bronchus PremiumSuperdimension, Ltd.2005551
+4K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+4K032333Cryocare CS Surgical SystemEndocare, Inc.200313—
+5K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+5K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+5K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+5K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20183—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+5K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+5K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+5K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc.20161—
+5K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+5K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+5K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+5K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+5K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+5K121449DirectpathCybernet Systems Co., Ltd.20120—
+5K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc.20113—
+5K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+5K093423Lungpoint Procedure PlanningBroncus Technologies, Inc.20091—
+5K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+5K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+5K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+5K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+5K062315Superdimension/Bronchus Premium 2Superdimension, Ltd.2006541
+5K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+6K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+6K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+6K200850Fujifilm Ultrasonic ProcessorFujifilm Corporation20200—
+6K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20192—
+6K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+6K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—