GE Aria X-ray Bone Densitometer

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

GE HEALTHCARE PTE. LTD.

Class:

Class C medical device

Manufactured by:

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Therapeutic area:

Radiology / Imaging

Therapeutic indications:

The bone densitometer is designed to estimate the bone mineral density of patients when medically indicated by their physicians. Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician. Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Provides an assessment of 10-year fracture risk using WHO FRAX model. Provides a standardized bone density report using data from the densitometer and physician-generated assessments based on the patient's demographics, which can assist the physician in communicating scan results to the patient and the patient's referring physician.

Product summary:

Device System Info:[System or Procedure Pack], System. Refer to model(s) info.; Models: ARIA - H8900AA, ARIA - H8900AB, enCORE Software v17 - H8940AP, enCORE Software v17 - H8950AP

Authorization date:

2019-07-10