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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 NameSELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
ApplicantLORAD, A HOLOGIC CO.
PMA NumberP010025
Supplement NumberS003
Date Received04/15/2003
Decision Date10/10/2003
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following user enhancements and components; an additional peripheral contrast enhancement (pce) based image processing mechanism; the addition of a high resolution fuji fm-dp l image printer; and updated labeling changes for the selenia full field digital mammography system (ffdm).
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