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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 NumberS005
Date Received07/29/2003
Decision Date10/31/2003
Reclassified Date 02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) AN UPGRADED ALGORITHM FOR THE ICAD SYSTEM, 2) USE OF THE ICAD SYSTEM DIRECTLY WITH IMAGES OBTAINED ON THE FISCHER SENOSCAN FFDM SYSTEM, AND 3) THE NEW INCLUSION OF WOMEN WITH BREAST IMPLANTS IN THE TARGET POPULATION IN THE INDICATIONS FOR USE (IFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ICAD SYSTEM WITH THE FOLLOWING INDICATIONS FOR USE: THE ICAD IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM CASES FOR PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, 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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