|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||SENOGRAPHE DS 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|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for senographe essential full field digital mammography system with increased detector area to accommodate a larger range of breast sizes for the purpose of screening and diagnosis.