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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.
 
DeviceSENOSCAN 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.
35 crosby dr.
bedford, MA 01730
PMA NumberP010017
Supplement NumberS004
Date Received07/22/2003
Decision Date05/12/2004
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 CHANGES IN THE X-RAY FILTER, SKIN LINE ALGORITHM, OPERATOR'S MANUAL AND QC MANUAL CHANGES UNDER MQSA.
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