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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 NumberS005
Date Received05/07/2004
Decision Date02/18/2005
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of automatic exposure (aec) system, and related changes in operator's manual and qc test and qc manual under mqsa.
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