75df9b08-9b19-4f76-82a0-0059bccce4a2UpdatePublished32018-07-062016-12-13In Commercial Distribution00815212021237PrimaryGS1Vacuum BagVB20251933506164Izi Medical Products, LLC1falsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK13212400040895Vacuum-mould patient positioning systemAn assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).falseActiveIYEAccelerator, Linear, Medicalfalsefalse