510(k) Report

Devices descending from K934523

32 later devices reach Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp.20081—
+1K991237Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc.199921
+1K991523TLC Pediatric Frame, Model TLC-SysRadionics, Inc.19990—
+1K972324Leksell Stereotactic SystemElekta Instrument AB199871
+1K962155Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc.19968—
+1K960338Stereotactic Body FrameElekta Instrument AB199613—
+2K260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLC20260—
+2K153270TruGuard Custom Tongue and Jaw PositionerBionix Development Corp.20164—
+2K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp.20110—
+2K092192Waypoint Stereotactic SystemFHC, Inc.20104—
+2K050377NBD Head ScrewNew Business Development, LLC20050—
+2K031631Stereotactic Body Frame, Model Cod. 70-1A3D Line USA, Inc.20030—
+2K991636Elekta Stereotactic GuideElekta Instrument AB19990—
+2K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco)19997—
+2K982463Extracranial Radiotherapy SystemHowmedica, Inc.19988—
+2K970291Accessories to the Stereotactic Body FramElekta Instrument AB19979—
+3K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC20260—
+3K231141STarFix Designer Software C0265FHC, Inc.20230—
+3K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+3K200652Lollipop BiteBlockRadtec Medical Devices, Inc.20200—
+3K183374GrayDuck StentPoll Medical, LLC20192—
+3K132611Microtable SystemFred Haer Company, Inc.20141—
+3K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp.20106—
+4K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc.20240—
+4K232293kallisio stentra™ oral stentKallisio, Inc.20230—
+4K231852BinkieRTPapricalab20230—
+4K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.20135—
+5K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions201801
+5K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions20163—
+6K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+6K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix20170—
+7K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—