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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 NumberS004
Date Received12/31/2003
Decision Date03/02/2004
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for selenia ffdm system for use in a mobile environment and qc manual changes.
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