PMA P010058
- Device
- OSTEOSPACE
- Applicant
- Medilink
- PMA number
- P010058
- Product code
- MUA
- Decision date
- 2004-03-15
- Classification
- Radiology
- Generic name
- Bone sonometer
- 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.
Current openFDA PMA Record#
- Device
- OSTEOSPACE
- Applicant
- Medilink
- PMA number
- P010058
- Product code
- MUA
- Generic name
- Bone sonometer
- Decision date
- 2004-03-15
- Decision code
- APRL
- Date received
- 2001-10-03
- 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.