|Trade Name||SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|
|Classification Name||full field digital,system,x-ray,mammographic|
|Generic Name||digital mammographic x-ray system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes in two software modifications that have been made to the acquisition workstation (aws) and for an additional supplier for the conditioner (chiller for the image receptor). The device, as modified, will be marketed under the trade name senographe ds full field digital mammography system and is indicated as follows: the senographe ds full field digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The senographe ds full field digital mammography system is intended to be used in the same clinical applications as traditional film-based mammographic system.