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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.
 
DeviceSELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
HOLOGIC, INC.
36 apple ridge road
danbury, CT 06810
PMA NumberP010025
Supplement NumberS002
Date Received03/28/2003
Decision Date09/24/2003
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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