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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 D
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP970058
Supplement NumberS021
Date Received11/19/2004
Decision Date01/05/2005
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXPAND THE USE OF THE IMAGECHECKER D TO ALLOW COMPUTER AIDED DETECTION (CAD) PROCESSING OF FULL-FLIED DIGITAL MAMMOGRAPHY (FFDM) IMAGES ACQUIRED WITH THE SIEMENS NOVATION FFDM SYSTEM.
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