Device Dossier

MRI system, full-body, superconducting magnet

Device Dossier for MRI system, full-body, superconducting magnet (MRI system, full-body, superconducting magnet, Class IIa, sponsor Fujifilm). ARTG…

Intended purpose

The system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

TGA Public Summary