Bone Sonometer
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- ACHILLES EXPRESS ULTRASONOMETER
- PMA Number
- P970040
- Device Class
- FDA Class 2
- Product Code
- MUA
- Generic Name
- Bone sonometer
- Regulation Number
- 892.1180
- Medical Specialty
- Radiology
- Advisory Committee
- Radiology
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- June 26, 1998
- Date Received
- September 2, 1997
- Expedited Review
- N
- Docket Number
- 98M-0715
Advisory Committee Statement
The device is indicated as follows: The Achilles+ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffnes Index indicateds risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at teh spine or hip. Stiffness Index results expressed as T-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are T-scores or obtained by X-ray absorpiometry. either the Stiffness Index T-score or X-ray absorptiometry T-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The Stiffness Index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for moniotirng bone changes.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUA | Bone Sonometer | FDA class 2 | Radiology |