PMA P000055
- Device
- UBIS 5000 BONE SONOMETER
- Applicant
- Diagnostic Medical Systems
- PMA number
- P000055
- Product code
- MUA
- Decision date
- 2001-07-17
- Classification
- Radiology
- Generic name
- Bone sonometer
- Approval order statement
- APPROVAL FOR THE UBIS 5000. THE UBIS 5000 IS A QUANTITATIVE ULTRASOUND (AUS) BONE SONOMETER AND IS INDICATED FOR THE MEASUREMENT OF BROADBAND ULTRASOUND ATTENUATION (BUA) OF THE CALCANEUS, AS AN AID TO DIAGNOSE OSTEOPOROSIS AND TO ESTIMATE THE RISK OF SUBSEQUENT ATRAUMATIC FRACTURE. THE OUTPUT IS EXPRESSED IN TERMS OF BOTH BUA AND T-SCORE.
Current openFDA PMA Record#
- Device
- UBIS 5000 BONE SONOMETER
- Applicant
- Diagnostic Medical Systems
- PMA number
- P000055
- Product code
- MUA
- Generic name
- Bone sonometer
- Decision date
- 2001-07-17
- Decision code
- APRL
- Date received
- 2000-12-18
- Approval order statement
- APPROVAL FOR THE UBIS 5000. THE UBIS 5000 IS A QUANTITATIVE ULTRASOUND (AUS) BONE SONOMETER AND IS INDICATED FOR THE MEASUREMENT OF BROADBAND ULTRASOUND ATTENUATION (BUA) OF THE CALCANEUS, AS AN AID TO DIAGNOSE OSTEOPOROSIS AND TO ESTIMATE THE RISK OF SUBSEQUENT ATRAUMATIC FRACTURE. THE OUTPUT IS EXPRESSED IN TERMS OF BOTH BUA AND T-SCORE.