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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 M5000D
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantHOLOGIC, INC.
PMA NumberP970058
Supplement NumberS025
Date Received02/08/2012
Decision Date09/21/2012
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for improvements in the cad algorithm, updated digital test database and support for ge senographe essential ffdm.
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