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

This is a diagnostic general-purpose magnetic resonance imaging (MRI) device that is intended to be used to scan any targeted area of the body (full-body imaging). It has a 75-cm, ultra-wide-bore 3.0T MRI with a 60-cm field of view and high homogeneity. It has a table weight capacity of 310Kg and a 3.5 MW gradient amplifier, and a lighting environment allowing for routine clinical workflow for 2D, 3D, and 4D MR exams

TGA Public Summary