510(k) Report

Devices descending from K892425

25 later devices reach STP Complete Module Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991706Virtuoso-Stereotaxic Planning SoftwareStryker Corp.19990—
+1K982463Extracranial Radiotherapy SystemHowmedica, Inc.19988—
+1K972324Leksell Stereotactic SystemElekta Instrument AB199871
+1K961484Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco)19960—
+1K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc.199617—
+1K946033Leibinger Stereoplan Plus Sterotactic Treatment Plan Ing Software PackageLeibinger GmbH19951—
+2K110644Praezis PlusTatramed Spol. S.R.O.20120—
+2K092192Waypoint Stereotactic SystemFHC, Inc.20104—
+2K050377NBD Head ScrewNew Business Development, LLC20050—
+2K010427Lorenz Fiducail ScrewWalter Lorenz Surgical, Inc.20011—
+2K991636Elekta Stereotactic GuideElekta Instrument AB19990—
+2K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco)19997—
+2K963502Csco Forehead Fixation SystemHowmedica Corp.19970—
+3K231141STarFix Designer Software C0265FHC, Inc.20230—
+3K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+3K160385Precision ScrewCryptych Pty, Ltd.20160—
+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—
+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—