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. |
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Device | SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 NASHUA, NH 03062 |
PMA Number | P010038 |
Supplement Number | S009 |
Date Received | 01/18/2005 |
Decision Date | 03/07/2005 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PRIVATE LABEL DISTRIBUTION (HOLOGIC, INC. TO DISTRIBUTE SECOND LOOK). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECURLOOK AND IS INDICATED FOR: THE SECURLOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC 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 OF THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW. |
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