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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
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP970058
Supplement NumberS003
Date Received12/16/1998
Decision Date02/10/1999
Reclassified Date 02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for proposed post approval study protocol for the ImageChecker M1000.
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