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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, DM, AND OEM-D (SOFTWARE VERSION 5.1)
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP970058
Supplement NumberS018
Date Received10/22/2003
Decision Date11/26/2003
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 FISCHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER D (DIGITAL MAMMOGRAPHY ONLY), IMAGECHECKER DM (DIGITAL AND ANALOG MAMMOGRAPHY), AND IMAGECHECKER OEM-D (DIGITAL MAMMOGRAPHY ONLY, SOLD BY FFDM VENDOR). THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.1. THE INDICATIONS FOR USE ARE: THE IMAGECHECKER D/DM.OEM-D 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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