This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the m-vu algorithm engine. The device is indicated for use in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read.
| Device | M-VU ALGORITHM ENGINE |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD, INC. |
| Date Received | 2010-02-01 |
| Decision Date | 2012-01-23 |
| Notice Date | 2012-01-26 |
| PMA | P100005 |
| Supplement | S |
| Product Code | MYN |
| Docket Number | 12M-0082 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ICAD, INC. 98 Spit Brook Road suite 100 nashua, NH 03062 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |