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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 Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
35 crosby dr.
bedford, MA 01730
PMA NumberP010017
Date Received03/13/2001
Decision Date09/25/2001
Reclassified Date 12/06/2010
Product Code
MUE[ Registered Establishments with MUE ]
Docket Number 01M-0509
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the senoscan(r) full field digital mammography system. The device is a dedicated mammography system intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The senoscan(r) full field digital mammography system is intended to be used in the same clinical applications as traditional film-based mammography systems.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S004 S005 S007