MRI system, full-body, superconducting magnet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Compliance Management Solutions

Class:

Class IIa

Manufactured by:

Galen MRI Systems Limited G/F Bio-Informatics Centre No 2 Science Park West Avenue Hong Kong Science Park, Shatin, New Territories Hong Kong - SAR of China

Therapeutic area:

37654 - MRI system, full-body, superconducting magnet

Therapeutic indications:

The EMMA 1.5T MRI System is indicated for use as a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.

Authorization status:

A

Authorization date:

2020-05-20