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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.
 
Device IMAGE CHECKER CAD
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP970058
Supplement NumberS026
Date Received10/17/2013
Decision Date02/10/2014
Reclassified Date 02/21/2020
Product Code MYN 
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 OF IMAGECHECKER CAD 10.0 FOR USE WITH C-VIEW IMAGES SYNTHESIZED BY THE HOLOGIC SELENIA DIMENSIONS SYSTEM.
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