||A device with demonstrated safety in the MR environment within defined conditions. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and the radiofrequency fields. Additional conditions, including specific configurations of the item, may be required.
||The device poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, non-metallic, and nonmagnetic.
||The device poses unacceptable risks to the patient, medical staff or other persons within the MR environment.
||Labelling does not contain MRI Safety Information - Information on the safety of using a device in a magnetic resonance (MR) environment has not been provided in the labelling by the labeller.