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The FDA reviewed Medical Device Reports (MDRs) and literature reports which describe adverse events, such as neurological deficits (e.g., focal motor deficits, aphasia, cognitive changes), increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes (e.g., visual field deficits, blurry vision) when these devices were used to treat intra-cranial lesions

(3) Ernst-angle wideband excitation for encoding all molecular information and supplementary variable-flip-angle excitations for encoding longitudinal relaxation

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These products are not subject to the same safety measures as medicationsand their quality may vary from one brand to the next