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 algorithm updates and the expansion to multiple mammography systems.
| Device | M-VU ALGOIRITHM ENGINE |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD, INC. |
| Date Received | 2012-05-21 |
| Decision Date | 2012-10-01 |
| PMA | P100005 |
| Supplement | S001 |
| Product Code | MYN |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| 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 |