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 | SECONDLOOK 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 | S012 |
Date Received | 07/12/2006 |
Decision Date | 04/04/2008 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF THE SECONDLOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY WITH FUJI MEDICAL SYSTEMS COMPUTED RADIOGRAPHY MAMMOGRAMS (CRM). THE DEVICE IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM FUJIFILM MEDICAL SYSTEMS COMPUTED RADIOGRAPHY SYSTEM (FUJI CRM) TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER AN INITIAL READING HAS BEEN COMPLETED. |
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