510(k) for CompuMed's bone scanning device:
This article was originally published in Clinica
Executive Summary
CompuMed has received clearance from the US FDA to market its automated OsteoGram 2000 device for performing bone density tests, in conjunction with standard X-ray equipment. The system takes under one minute to scan a simple hand X-ray and analyse the bone density. Approved for US Medicare reimbursement, the OsteoGram 2000 costs significantly less than bone densitometers currently available, said the company.