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.
Approval for m-vu® algorithm engine version 3. 1. 0. 0 with shorter execution time.
| Device | M-VU ALGORITHM ENGINE |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD, INC. |
| Date Received | 2014-05-19 |
| Decision Date | 2014-06-06 |
| PMA | P100005 |
| Supplement | S004 |
| Product Code | MYN |
| Advisory Committee | Radiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ICAD, INC. 98 Spit Brook Road suite 100 nashua, NH 03062 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100005 | Original Filing | |
| S007 | 2016-12-08 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | 2014-11-13 | Normal 180 Day Track |
| S004 | 2014-05-19 | Real-time Process |
| S003 | 2013-08-27 | Normal 180 Day Track |
| S002 | 2013-03-21 | Normal 180 Day Track |
| S001 | 2012-05-21 | Normal 180 Day Track |