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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantHOLOGIC, INC.
PMA NumberP970058
Supplement NumberS024
Date Received09/18/2006
Decision Date02/09/2007
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at hologic, inc. , bedford, massachusetts.
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