| 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. |
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| Device | ACHILLES EXPRESS ULTRASONOMETER |
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| Generic Name | Bone sonometer |
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| Regulation Number | 892.1180 |
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| Applicant | GE LUNAR CORP.
726 HEARTLAND TRAIL
MADISON, WI 53717 |
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| PMA Number | P970040 |
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| Date Received | 09/02/1997 |
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| Decision Date | 06/26/1998 |
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Reclassified Date
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08/18/2008 |
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| Product Code |
MUA |
| Docket Number | 98M-0715 |
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| Notice Date | 10/07/1998 |
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| Advisory Committee |
Radiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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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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