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 Emergo). ARTG record,…

Intended purpose

The iMRI systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that displays the internal structure and / or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The iMRI systems may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The iMRI systems may also be used for imaging in a multi-room suite.

TGA Public Summary