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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
36 apple ridge road
danbury, CT 06810
PMA NumberP010025
Date Received04/30/2001
Decision Date03/15/2002
Reclassified Date 12/06/2010
Product Code
MUE[ Registered Establishments with MUE ]
Docket Number 02M-0173
Notice Date 04/25/2002
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the lorad digital breast imager. The device generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film mammographic systems.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S012 S013 S015 S016 S017 S018 S019 S020