Med-Imaps TBS iNsight software

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

MEDICAL IMAGING SYSTEMS PTE. LTD.

Class:

Class B medical device

Manufactured by:

Med-Imaps SASU

Therapeutic area:

Radiology / Imaging

Therapeutic indications:

For use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates Trabecular Bone Score - TBS that is compared to those of the age-matched controls. Provides as an option an assessment of 10-year fracture risk – 10 year estimated probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO’s FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value; used as a complement to the data obtained from the DXA analysis and the clinical examination. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.

Product summary:

Device System Info:[Device with measuring function], [System or Procedure Pack], TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine DEXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls.; Models: TBS iNsight (Upgrade Program) - OS-UPG-300, TBS iNsight (Installation Program) - OS-LIC-STD-1-300

Authorization date:

2016-12-13