510(k) Report

Devices descending from K052260

56 later devices reach Superdimension/Bronchus 4.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052852Superdimension/Bronchus PremiumSuperdimension, Ltd.2005551
+2K062315Superdimension/Bronchus Premium 2Superdimension, Ltd.2006541
+3K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+4K110093Superdimension Marker Delivery KitSuperdimension, Inc.20114—
+4K102604I-Logic Inreach SystemSuperdimension, Ltd.20108—
+4K080271Inreach SystemSuperdimension, Ltd.200852—
+5K151376superDimension Navigation SystemCovidien, LLC20152—
+5K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc.20113—
+5K093810BF-NaviKgt, Inc.20101—
+5K090095Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20097—
+5K081379Modification to Inreach SystemSuperdimension, Ltd.200845—
+6K260009LungPoint Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Medical, Inc.20260—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K173244superDimension Navigation System V7.2Covidien, LLC20181—
+6K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K121449DirectpathCybernet Systems Co., Ltd.20120—
+6K091934IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Veran Medical Technologies, Inc.20092—
+6K092365Inreach System, Model AAS00161-02Superdimension, Ltd.20099—
+6K091160Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20095—
+6K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+6K082386Inreach Planning LaptopSuperdimension, Ltd.20080—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K191394ILLUMISITE PlatformCovidien, LLC201901
+7K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+7K110256The IC-Pro SystemPaieon, Inc.201115—
+7K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+7K093423Lungpoint Procedure PlanningBroncus Technologies, Inc.20091—
+7K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+7K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+8K133993Caas WorkstationPie Medical Imaging201410—
+8K120282CardnavPaieon, Inc.20120—
+8K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+8K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+8K113594C-THV SystemPaieon, Inc.20120—
+8K113076Caas a-ValvePie Medical Imaging BV20121—
+9K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+9K151780CAAS WorkstationPie Medical Imaging BV20169—
+9K143044CAAS A-ValvePie Medical Imaging BV20150—
+9K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+9K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+10K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+10K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+10K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+10K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+10K180019CAAS WorkstationPie Medical Imaging BV20188—
+11K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+11K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+11K251355X1-FFRSpectrawave, Inc.20250—
+11K232147CAAS WorkstationPie Medical Imaging BV20241—
+11K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+12K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+12K243769QFR (3.0)Qfr Solutions BV20250—
+12K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+13K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+13K221711AccuICASArteryFlow Technology Co., Ltd.20230—