|Trade Name||SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM|
|Classification Name||analyzer,medical image|
|Generic Name||computer-aided detection system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of the secondlook digital computer-aided detection system for mammography with fuji medical systems computed radiography mammograms (crm). The device is intended to identify and mark regions of interest on screening and diagnostic mammograms from fujifilm medical systems computed radiography system (fuji crm) to bring them to the attention of the radiologist after an initial reading has been completed.