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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 NumberS001
Date Received03/29/2002
Decision Date10/02/2002
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an amorphous selenium digital receptor, a change in the name of the product to selenia and the addition of a soft copy display for interpretation of screening and diagnostic mammograms. The device, as modified, will be marketed under the trade name selenia full field digital mammography system and is indicated for generating digital mammographic images that can be used for screening and diagnosis of breast cancer. The selenia full field digital mammography system is intended for use in the same clinical applications as traditional screen-film mammographic systems. Mammographic images can be interpreted on either hard copy film or the selenia soft copy review workstation. Also, approval for the addition of the lorad facility, danbury, connecticut, as a manufacturing site for the selenia full field digital mammography system.