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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.
 
DeviceIMAGE CHECKER (CAD) SYSTEM, M100
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP970058
Supplement NumberS011
Date Received09/28/2001
Decision Date11/13/2001
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF THE IMAGECHECKER M1000 WITH INPUT FROM THE GENERAL ELECTRIC MEDICAL SYSTEMS' SENOGRAPHE 2000 FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
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