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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.
 
DeviceSELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantHOLOGIC, INC.
36 Apple Ridge Road
Danbury, CT 06810
PMA NumberP010025
Supplement NumberS002
Date Received03/28/2003
Decision Date09/24/2003
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES IN THE SELENIA QC MANUAL: 1) CHANGE THE MINIMUM SCORES FOR THE ACR PHANTOM TEST TO 5 FIBERS, 4 SPECS, AND 4 MASSES FORM 4 FIBERS, 4 SPECS, AND 3 MASSES. 2) CHANGE THE SIGNAL-TO-NOISE TEST RESULT MINIMUM FROM 40 TO 35. THE 40 VALUE WAS BASED ON THE USE OF THE BR-12 PHANTOM, WHEREAS THE STANDARD PHANTOM IS THE ACT WITH A MINIMUM VALUE OF 35. 3) ADD A SPECIFICATION OF 28 K VP AND 65 MAS FOR PERFORMANCE OF QC TESTING.
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