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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.
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
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.