|Trade Name||IMAGECHECKER CT CAD SOFTWARE SYSTEM|
|Generic Name||system,image processing,radiological|
|Docket Number|| 04M-0323|
|Notice Date|| 07/22/2004|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the imagechecker ct cad software system - model ln-1000. This software system is indicated to assist radiologists in the detection of solid pulmonary nodules during review of multidetector ct (mdct) scans of the chest. It is intended to be used as an adjunct, alerting the radiologist - after his or her initial reading of the scan - to regions of interest (rois) that may have been initially overlooked.