510(k) Report

Devices descending from K951994

148 later devices reach Olympus EU-M30 Endoscopic Ultrasound Center through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+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—
+9K230778EndoCorePraxis Medical, LLC20230—
+9K173244superDimension Navigation System V7.2Covidien, LLC20181—
+9K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+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—
+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
+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—