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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namebone sonometer
Generic Namebone sonometer
Regulation Number892.1180
726 heartland trail
madison, WI 53717
PMA NumberP970040
Date Received09/02/1997
Decision Date06/26/1998
Reclassified Date 08/18/2008
Product Code
MUA[ Registered Establishments with MUA ]
Docket Number 98M-0715
Notice Date 10/07/1998
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order 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.
Supplements: S001 S002 S003