510(k) Report

Devices descending from K111340

13 later devices reach Head and Neck Immobilization System, Body Immobilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142420Patient Positioning DevicesMacromedics BV20157—
+1K121284Chabner XRT GarmentsChabner Xrt, LLC20130—
+1K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.20135—
+2K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV20231—
+2K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV20220—
+2K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV20222—
+2K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+2K193243Alta Multipurpose DeviceQfix20200—
+2K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions201801
+2K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions20163—
+3K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…Macromedics BV20250—
+3K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+3K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix20170—