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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 M1000 SYSTEM
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP970058
Supplement NumberS016
Date Received05/08/2003
Decision Date09/10/2003
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW SOFTWARE RELEASE (V5.0) THAT: 1) PROVIDES THE USER WITH A CHOICE OF TWO OPERATING POINTS (ONE WITH HIGHER SENSITIVITY AND INCREASED FALSE MARKS AND THE OTHER WITH LOWER FALSE MARKS WITH DECREASED SENSITIVITY, CHOSEN AT THE TIME OF DEVICE INSTALLATION) FOR USE WITH FILM/SCREEN IMAGES ONLY; 2) WHEN PACKAGED WITH V3.1A SOFTWARE IN A SINGLE IMAGE CHECKER HOUSING, ALLOWS THE PROCESSING OF BOTH ANALOG AND GE FFDM IMAGES; 3) ALLOWS CAD PROCESSING OF GE FFDM DICOM IMAGES FORMATTED FOR PRESENTATION; AND 4) REDUCES THE NUMBER OF OVERSIZED MALIGNANT CALCIFICATION CLUSTERS MISSED BY EARLIER ALGORITHMS.
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