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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFULL FIELD DIGITAL MAMMOGRAPHY
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantFujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford, CT 06902
PMA NumberP050014
Supplement NumberS002
Date Received07/15/2009
Decision Date08/11/2009
Reclassified Date12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) CHANGES IN THE CNR WEEKLY CHECK - QC TECHNOLOGIST; 2) CHANGE TO THE MONITOR QC - MEDICAL PHYSICIST TEST LUMINANCE RESPONSE TEST; 3) NEW TERMINOLOGY REGARDING USE OF THE TERM -ACQUISITION WORKSTATION; AND 4) TRADE NAME CHANGE TO ASPIRE.
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