|Trade Name||SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|
|Classification Name||full field digital,system,x-ray,mammographic|
|Generic Name||full field digital,system,x-ray,mammographic|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the image chain software, specifically the automatic operating parameters (aop) and the auto-contrast and thickness compensation algorithms; the addition of some new features to the acquisition work station and the review work station that provide more options for image display and printing; and revised labeling to address the changes.