|Trade Name||GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM|
|Classification Name||full field digital,system,x-ray,mammographic|
|Generic Name||digital mammographic x-ray system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the amorphous silicon array design used in the detector of the senographe essential full field digital mammography system. The proposed modifications include the following: 1) reducing the number of layers in the detector amorphous silicon array; 2) change in the detector firmware to allow the detector configuration to be communicated to the system image detector controller (idc); 3) idc software to automatically determine is a detector with the proposed modification is installed on the system and properly select the proper configuration table; and 4) corresponding changes in the incoming acceptance criteria testing station for the modified detector.