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 DIGITAL V7.2 CAD |
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 | S016 |
Date Received | 08/10/2012 |
Decision Date | 11/09/2012 |
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 SECONDLOOK DIGITAL V7.2 CAD FOR USE WITH THE PHILIPS MICRODOSE FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM. |
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