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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.
 
DeviceIMAGECHECKER M1000 SYSTEM
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP970058
Supplement NumberS006
Date Received01/14/2000
Decision Date04/17/2000
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 for a software change that impoves the device sensitivity for detecting masses and reduces the number of extraneous maks produced per case.
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