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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameACHILLES EXPRESS ULTRASONOMETER
Classification Namebone sonometer
Generic Nameultrasonometer
Regulation Number892.1180
ApplicantGE LUNAR CORP.
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 
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