Ultrasound system, bone absorptiometer

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

GE Healthcare Australia Pty Ltd

Class:

Class IIa

Manufactured by:

GE Medical Systems (China) Co Ltd No 19 Changjiang Road Wuxi National Hi-Tech Dev Zone, Jiangsu, 214028 China

Therapeutic area:

40779 - Ultrasound system, bone absorptiometer

Therapeutic indications:

This device is intended to measure ultrasound variables of the os calcis to provide a clinical measure called stiffness index. The stiffness index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by x-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

Authorization status:

A

Authorization date:

2011-05-19