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. |
|
Device | M-VU ALGORITHM ENGINE |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 NASHUA, NH 03062 |
PMA Number | P100005 |
Supplement Number | S004 |
Date Received | 05/19/2014 |
Decision Date | 06/06/2014 |
Reclassified Date
|
02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR M-VU® ALGORITHM ENGINE VERSION 3.1.0.0 WITH SHORTER EXECUTION TIME. |
|
|