PMA P970040S001

Device: ACHILLES EXPRESS ULTRASONOMETER
Applicant: Ge Lunar Corp.
PMA number: P970040
Supplement: S001
Product code: MUA
Decision date: 1999-04-23
Generic name: Bone sonometer
Approval order 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 x-ray absorptiometry at the spine or hip.

Current openFDA PMA Record#

Device: ACHILLES EXPRESS ULTRASONOMETER
Applicant: Ge Lunar Corp.
PMA number: P970040
Supplement: S001
Product code: MUA
Generic name: Bone sonometer
Decision date: 1999-04-23
Decision code: APPR
Date received: 1999-02-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 x-ray absorptiometry at the spine or hip.