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 | ICAD |
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 | S001 |
Date Received | 10/28/2002 |
Decision Date | 02/24/2003 |
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 USE OF THE 3.9.3.7 VERSION OF THE SOFTWARE. THE NEW SOFTWARE IS INTENDED TO IMPROVE THE OVERALL SENSITIVITY, IMPROVE THE BREAST SEGMENTATION PROCESS, REDUCE THE FALSE MARKER RATE AND IMPROVE THE OVERALL CONSISTENCY OF THE ALGORITHM. THE CLINICAL PERFORMANCE CLAIMS ARE NOT CHANGED. |
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