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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 CAD SYSTEM FOR MAMMOGRAPHY
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP970058
Supplement NumberS022
Date Received11/28/2005
Decision Date06/23/2006
Reclassified Date 02/21/2020
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
Approval Order Statement  
APPROVAL OF NEW LABELING THAT WILL PRESENT THE SPECIFICITY OF CAD MARKS GENERATED BY R2 IMAGECHECKER COMPUTER AIDED DETECTION SYSTEM AS WELL AS ITS ABILITY TO MARK ACTIONABLE PRIORS. THE INDICATIONS FOR USE REMAIN AS PREVIOUSLY APPROVED: THE IMAGECHECKER M5000 IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
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