12564e62-3fcd-448c-909a-28b31dafd14dNewPublished12020-10-022020-09-24In Commercial Distribution00810050242011PrimaryGS1Scancoat106-SCB081253414DOMICO MED-DEVICE, LLC1SCANCOAT®, WEDGE, 6.63 X 6.63 X 12.00falsetruefalsefalsefalsefalsetruefalsetruefalsefalsefalsetrueLabeling does not contain MRI Safety Informationfalsefalse41058Multifunction body cushionA soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.falseActive61131Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.falseActiveKXJTable, RadiologicCCXSupport, Patient PositionHeightWidthLengthfalsefalse