|Classification Name||bone sonometer|
|Generic Name||ultrasound bone sonometer|
|Docket Number|| 05M-0024|
|Notice Date|| 01/21/2005|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the osteospace. The osteospace is a quantitative ultrasound bone sonometer device (qus) to be used for the measurement of broadband ultrasound attenuation (bua) of the calcaneus, as an aid, together with other clinical risk factors, to diagnose osteoporosis and other medical conditions leading to reduced bone strength and to estimate the risk of subsequent atraumatic fracture. The output is expressed in terms of bua, t-score, and z-score.