510(k) Report

Devices descending from K060903

47 later devices reach IG4 Image Guided System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152473CAS-One IRCascination AG20163—
+1K132108MAXIOPerfint Healthcare Pvt, Ltd.201427—
+1K110812CT-Guide Needle Guidance SystemActiviews, Ltd.20112—
+1K093995IG 4 Image Guided SystemVeran Medical Technologies, Inc.20102—
+1K091934IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Veran Medical Technologies, Inc.20092—
+1K093146IG4 Image Guided System, Model: Sys-0200Veran Medical Technologies, Inc.200935
+1K083728Invision SystemInneroptic Technology, Inc.20098—
+2K232022CAS-One IRCascination AG20241—
+2K223758EpioneQuantum Surgical Sas202302
+2K211645EpioneQuantum Surgical Sas20221—
+2K191332XACT Robotic SystemXact Robotics, Ltd.20193—
+2K163643Sirio H3Masmec Spa20170—
+2K151414IQQA GuideEdda Technology20151—
+2K150313Ablation ConfirmationNeuwave Medical, Inc.201516—
+2K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+2K121479AIMInneroptic Technology, Inc.20125—
+2K120300CT-Guide Needle Guidance SystemActiviews, Ltd.20120—
+2K113063CT-Guide Needle Guidance SystemActiviews, Ltd.20111—
+2K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc.20111—
+3K261225CAS-One IRCascination AG20260—
+3K202297Aline Ablation IntelligenceMirada Medical, Ltd.202011—
+3K201586XACT Robotic SystemXact Robotics, Ltd.20202—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+3K161285Ablation ConfirmationNeuwave Medical, Inc.20163—
+3K143024CAS-One LiverCascination AG20150—
+3K141806Clear Guide OneClear Guide Medical20142—
+3K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+4K240796myAblation Guide (VB80A)Siemens Healthcare GmbH20241—
+4K222938Ablation-fitR.a.W. S.R.L20230—
+4K223639VisAble.IOTechsomed20232—
+4K220256MIM-AblationMim Software, Inc.20224—
+4K213759XACT Robotic System, ACE ModelXact Robotics, Ltd.20220—
+4K221116XACT ACE Robotic SystemXact Robotics, Ltd.20220—
+4K211529NAVIRFA ScopeNavifus Corporation20220—
+4K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+4K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+4K171022Ablation ConfirmationNeuwave Medical, Inc.20172—
+5K253264myAblation Guide (VC10A)Siemens Healthcare GmbH20260—
+5K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+5K232514MIM – Dose AnalysisMim Software, Inc.20240—
+5K240773VisAble.IOTechsomed20241—
+5K192427Ablation ConfirmationNeuwave Medical, Inc.20191—
+6K251931BioTraceIO Vision (V1.7)Techsomed Medical Technologies20250—
+6K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+6K232227Ablate-IQNeuwave Medical, Inc.20240—
+7K251883MIM – LesionID ProMim Software, Inc.20250—