|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.|
|Classification Name||analyzer,medical image|
|Generic Name||analyzer, medical image, chest x-ray|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new trade name. The device, as modified, will be marketed under the trade name onguard and is indicated to identify and mark regions of interest (rois) on frontal chest radiographic films from adult males with an increased risk for lung cancer to bring rois to the attention of the radiologist after the initial reading has been completed. Thus the system assists the radiologist in minimizing observational oversights by identifying areas on the original chest films that may warrant a second review.