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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 Nameanalyzer,medical image
Generic Nameanalyzer,medical image
3020 south tech blvd.
miamisburg, OH 45342-4860
PMA NumberP000041
Supplement NumberS006
Date Received07/26/2007
Decision Date08/30/2007
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product 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.