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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 M5000D AND M5000DM, (SOFTWARE VERSION 5.2)
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP970058
Supplement NumberS019
Date Received03/01/2004
Decision Date04/07/2004
Reclassified Date 02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF THE IMAGECHECKER SYSTEM WITH THE HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHIC SYSTEM AND EQUIVALENT PRIVATE LABEL DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER M5000D (DIGITAL MAMMOGRAPHY ONLY) AND IMAGECHECKER M5000DM (DIGITAL AND ANALOG MAMMOGRAPHY). THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.2. THE INDICATIONS FOR USE ARE: THE IMAGECHECKER M5000D/DM 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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