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 United Imaging…

Intended purpose

The uMR 670/uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

TGA Public Summary