510(k) Report

Devices descending from K081379

45 later devices reach Modification to Inreach System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+1K091934IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Veran Medical Technologies, Inc.20092—
+1K092365Inreach System, Model AAS00161-02Superdimension, Ltd.20099—
+1K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+1K082386Inreach Planning LaptopSuperdimension, Ltd.20080—
+2K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+2K110256The IC-Pro SystemPaieon, Inc.201115—
+2K110093Superdimension Marker Delivery KitSuperdimension, Inc.20114—
+2K102604I-Logic Inreach SystemSuperdimension, Ltd.20108—
+2K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+2K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+2K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+3K151376superDimension Navigation SystemCovidien, LLC20152—
+3K133993Caas WorkstationPie Medical Imaging201410—
+3K120282CardnavPaieon, Inc.20120—
+3K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+3K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+3K113594C-THV SystemPaieon, Inc.20120—
+3K113076Caas a-ValvePie Medical Imaging BV20121—
+3K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc.20113—
+4K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K173244superDimension Navigation System V7.2Covidien, LLC20181—
+4K151780CAAS WorkstationPie Medical Imaging BV20169—
+4K143044CAAS A-ValvePie Medical Imaging BV20150—
+4K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+4K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+5K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+5K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+5K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+5K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K191394ILLUMISITE PlatformCovidien, LLC201901
+5K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+6K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+6K251355X1-FFRSpectrawave, Inc.20250—
+6K232147CAAS WorkstationPie Medical Imaging BV20241—
+6K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243769QFR (3.0)Qfr Solutions BV20250—
+7K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+8K221711AccuICASArteryFlow Technology Co., Ltd.20230—