ACHILLES EXPRESS ULTRASONOMETER
FDA premarket approval P970040 · decided 1998-06-26
Approval details
- PMA number
- P970040
- Trade name
- ACHILLES EXPRESS ULTRASONOMETER
- Generic name
- Bone sonometer
- Applicant
- Ge Lunar Corp.
- Date received
- 1997-09-02
- Decision date
- 1998-06-26
- Days to decision
- 297 days
- Decision code
- APRL
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Madison, WI
- 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 obtai
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DPX SERIES BRAVO DUO BONE DENSITOMETER (K030962) | Ge Lunar Corp. | 2003-07-25 |
| DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE (K023554) | Ge Lunar Corp. | 2002-12-20 |
| ADVANCED HIP ASSESSMENT SOFTWARE (K011917) | Ge Lunar Corp. | 2001-08-03 |