510(k) Report

Devices descending from K926514

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+6K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+6K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+6K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+6K152922ViziShot FLEXSpiration, Inc.20166—
+6K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+6K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+6K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+6K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+7K250145Biopsy Port AdapterEndosound, Inc.20250—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+7K231267ClearTipFinemedix Co., Ltd.20231—
+7K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+7K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+7K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+7K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+7K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+7K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+7K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+7K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+7K110093Superdimension Marker Delivery KitSuperdimension, Inc.20114—
+7K102604I-Logic Inreach SystemSuperdimension, Ltd.20108—
+7K101333Cryocare CS Surgical SystemEndocare, Inc.201082
+7K080271Inreach SystemSuperdimension, Ltd.200852—
+8K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+8K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+8K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+8K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+8K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+8K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+8K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+8K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+8K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+8K151376superDimension Navigation SystemCovidien, LLC20152—
+8K141110Cryocare CS Surgical SystemHealthtronics20157—
+8K081379Modification to Inreach SystemSuperdimension, Ltd.200845—
+9K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+9K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+9K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+9K230778EndoCorePraxis Medical, LLC20230—
+9K173244superDimension Navigation System V7.2Covidien, LLC20181—
+9K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+9K153489Cryocare CS Surgical SystemHealthtronics20165—
+9K151968Cryocare CS-3 Surgical System version 5Healthtronics20156—
+9K091934IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Veran Medical Technologies, Inc.20092—
+9K092365Inreach System, Model AAS00161-02Superdimension, Ltd.20099—
+9K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+9K082386Inreach Planning LaptopSuperdimension, Ltd.20080—
+10K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+10K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+10K191394ILLUMISITE PlatformCovidien, LLC201901
+10K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+10K110256The IC-Pro SystemPaieon, Inc.201115—
+10K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+10K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+10K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+11K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+11K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+11K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+11K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+11K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+11K133993Caas WorkstationPie Medical Imaging201410—
+11K120282CardnavPaieon, Inc.20120—
+11K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+11K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+11K113594C-THV SystemPaieon, Inc.20120—
+11K113076Caas a-ValvePie Medical Imaging BV20121—
+12K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+12K151780CAAS WorkstationPie Medical Imaging BV20169—
+12K143044CAAS A-ValvePie Medical Imaging BV20150—
+12K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+12K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+13K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+13K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+13K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+13K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+13K180019CAAS WorkstationPie Medical Imaging BV20188—
+14K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+14K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+14K251355X1-FFRSpectrawave, Inc.20250—
+14K232147CAAS WorkstationPie Medical Imaging BV20241—
+14K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+15K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+15K243769QFR (3.0)Qfr Solutions BV20250—
+15K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+16K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+16K221711AccuICASArteryFlow Technology Co., Ltd.20230—