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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 NameHOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital mammography system
Regulation Number892.1715
ApplicantHOLOGIC, INC.
PMA NumberP010025
Supplement NumberS009
Date Received11/24/2006
Decision Date01/17/2007
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for mounting hologic securview reference image viewer into the selenia acquisition workstation (aws) cabinet for retrieving and displaying patient?s prior images but not for primary image diagnosis.
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