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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 NumberS001
Date Received03/29/2002
Decision Date10/02/2002
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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