|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.|
|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 modifications to the approved system to permit use of an optional contrast enhancement algorithm (dynamic range management) introduction of new display protocols and minor changes in the display scenarios, and addition of keyboard shortcuts for window width/window level settings. The supplement also includes changes in the labeling to reflect the modifications listed above.