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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.
 
DevicePROMINENT CALC FEATURE MARKER
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP970058
Supplement NumberS009
Date Received12/08/2000
Decision Date01/22/2001
Product Code
MYN[ Registered Establishments with MYN ]
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 THE ADDITION OF A NEW CALCIFICATION MARKER. THIS MARKER (A CIRCLE) IS INTENDED TO ENABLE THE USER OF THE IMAGECHECKER TO DIFFERENTIATE OBVIOUS CALCIFICATIONS FROM MORE SUBTLE CALCIFICATIONS THAT APPEAR IN ANALYZED MAMMOGRAMS.
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