|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||M-VU ALGORITHM ENGINE|
|Classification Name||analyzer,medical image|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of m-vu algorithm engine version 2. 1. 2. 0 for use with the fuji fcrm computed radiography (cr) full-field digital mammography (ffdm) system.