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.