PMA P980010
- Device
- DTU-ONE ULTRASOUND SCANNER
- Applicant
- OSTEOMETER MEDITECH A/S
- PMA number
- P980010
- Product code
- MUA
- Decision date
- 2000-09-19
- Generic name
- Bone Sonometer
- Approval order statement
- APPROVAL FOR THE DTU-ONE ULTRASOUND SCANNER. THE DTU-ONE IS INTENDED TO PERFORM QUANTITATIVE ULTRASOUND MEASUREMENT OF THE CALCANEUS (THE HEEL BONE), THE RESULTS OF WHICH CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN DIAGNOSIS OF OSTEOPOROSIS (T-SCORE) AND IN THE DETERMINATION OF FRACTURE RISK IN MEN AND WOMEN. THE MEASUREMENT MAY ALSO BE USED IN CAUCASIAN WOMEN TO AID IN THE DETECTION OF MEDICAL CONDITIONS, OTHER THAN AGE-RELATED BONE LOSS, THAT LEAD TO REDUCED BONE DENSITY.
- Summary
- Summary of Safety and Effectiveness
Current openFDA PMA Record
- Device
- DTU-ONE ULTRASOUND SCANNER
- Applicant
- Osteometer Meditech A/S
- PMA number
- P980010
- Product code
- MUA
- Generic name
- Bone sonometer
- Decision date
- 2000-09-19
- Decision code
- APRL
- Date received
- 1998-04-15
- Approval order statement
- APPROVAL FOR THE DTU-ONE ULTRASOUND SCANNER. THE DTU-ONE IS INTENDED TO PERFORM QUANTITATIVE ULTRASOUND MEASUREMENT OF THE CALCANEUS (THE HEEL BONE), THE RESULTS OF WHICH CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN DIAGNOSIS OF OSTEOPOROSIS (T-SCORE) AND IN THE DETERMINATION OF FRACTURE RISK IN MEN AND WOMEN. THE MEASUREMENT MAY ALSO BE USED IN CAUCASIAN WOMEN TO AID IN THE DETECTION OF MEDICAL CONDITIONS, OTHER THAN AGE-RELATED BONE LOSS, THAT LEAD TO REDUCED BONE DENSITY.