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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.
Classification Nametester,acoustic,bone quality
Generic Nametester,acoustic,bone quality
2981 copper rd.
santa clara, CA 
PMA NumberP990039
Date Received07/14/1999
Decision Date08/01/2000
Withdrawal Date 10/08/2010
Product Code
Docket Number 00M-1437
Notice Date 08/16/2000
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the qus-2 calcaneal ultrasonometer. The qus-2 ultrasonometer is a medical device that utilizes quantitative ultrasound for evaluation of the calcaneus. Its bua (broadband ultrasound attenuation) value is intended to be used as an aid in the diagnosis of osteoporosis and in the determination of risk of subsequent atraumatic fracture.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001