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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.
 
DeviceICAD SYSTEM
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantICAD, INC.
98 SPIT BROOK ROAD
SUITE 100
NASHUA, NH 03062
PMA NumberP010038
Supplement NumberS007
Date Received04/28/2004
Decision Date05/19/2004
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 REPLACING THE ICAD SYSTEM'S CAD SOFTWARE WITH THE SECOND LOOK CAD SOFTWARE AND INCREASING THE SYSTEM MEMORY FROM 1 GIGABYTE TO 2 GIGABYTES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK 200 AND IS INDICATED FOR: SECOND LOOK IS A COMPUTED SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, TO BRING 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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