ACHILLES EXPRESS ULTRASONOMETER
FDA premarket approval P970040/S001 · decided 1999-04-23
Approval details
- PMA number
- P970040
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACHILLES EXPRESS ULTRASONOMETER
- Generic name
- Bone sonometer
- Applicant
- Ge Lunar Corp.
- Date received
- 1999-02-16
- Decision date
- 1999-04-23
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Madison, WI
- Statement
- Approval for a design change that was primarily to replace the open water bath with water enclosed in silicone membranes. The device, as modified, will be marketed under the trade name Achilles Express and is indicated for: The Achilles Express ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |