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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
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP970058
Supplement NumberS012
Date Received02/05/2002
Decision Date02/11/2002
Reclassified Date02/21/2020
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE NEW EFFICACY CLAIM IN PMA SUPPLEMENT 7 (VERSION 2.2 SOFTWARE). THE CHANGE IS FROM: "FOR EVERY 100,000 CANCERS CURRENTLY DETECTED BY SCREENING MAMMOGRAPHY, THE USE OF THE IMAGECHECKER COULD RESULT IN EARLY DETECTION OF AN ADDITIONAL 30,500 BREAST CANCERS." TO: "USE OF THE IMAGECHECKER COULD RESULT IN EARLIER DETECTION OF UP TO 23.4% (95% CI, 19.4% - 27.4%) OF THE CANCERS CURRENTLY DETECTED WITH SCREENING MAMMOGRAPHY IN THOSE WOMEN WHO HAD A PRIOR SCREENING MAMMOGRAM 9-24 MONTHS EARLIER."
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