510(k) Report

Devices descending from K042438

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090095Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20097—
+1K080581VB Image ViewerOlympus Medical Systems Corporation20082—
+1K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+1K052260Superdimension/Bronchus 4.1Superdimension, Ltd.2005562
+1K051585F-400 SystemMauna Kea Technologies200513—
+2K260009LungPoint Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Medical, Inc.20260—
+2K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies20147—
+2K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc.201112—
+2K093810BF-NaviKgt, Inc.20101—
+2K091160Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20095—
+2K052852Superdimension/Bronchus PremiumSuperdimension, Ltd.2005551
+3K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+3K121449DirectpathCybernet Systems Co., Ltd.20120—
+3K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc.20113—
+3K093423Lungpoint Procedure PlanningBroncus Technologies, Inc.20091—
+3K062315Superdimension/Bronchus Premium 2Superdimension, Ltd.2006541
+4K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+4K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+4K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+5K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+5K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K110093Superdimension Marker Delivery KitSuperdimension, Inc.20114—
+5K102604I-Logic Inreach SystemSuperdimension, Ltd.20108—
+5K080271Inreach SystemSuperdimension, Ltd.200852—
+6K151376superDimension Navigation SystemCovidien, LLC20152—
+6K081379Modification to Inreach SystemSuperdimension, Ltd.200845—
+7K173244superDimension Navigation System V7.2Covidien, LLC20181—
+7K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+7K091934IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Veran Medical Technologies, Inc.20092—
+7K092365Inreach System, Model AAS00161-02Superdimension, Ltd.20099—
+7K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+7K082386Inreach Planning LaptopSuperdimension, Ltd.20080—
+8K191394ILLUMISITE PlatformCovidien, LLC201901
+8K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+8K110256The IC-Pro SystemPaieon, Inc.201115—
+8K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+8K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+8K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+9K133993Caas WorkstationPie Medical Imaging201410—
+9K120282CardnavPaieon, Inc.20120—
+9K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+9K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+9K113594C-THV SystemPaieon, Inc.20120—
+9K113076Caas a-ValvePie Medical Imaging BV20121—
+10K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+10K151780CAAS WorkstationPie Medical Imaging BV20169—
+10K143044CAAS A-ValvePie Medical Imaging BV20150—
+10K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+10K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+11K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+11K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+11K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+11K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+11K180019CAAS WorkstationPie Medical Imaging BV20188—
+12K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+12K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+12K251355X1-FFRSpectrawave, Inc.20250—
+12K232147CAAS WorkstationPie Medical Imaging BV20241—
+12K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+13K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+13K243769QFR (3.0)Qfr Solutions BV20250—
+13K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+14K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+14K221711AccuICASArteryFlow Technology Co., Ltd.20230—