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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceONGUARD
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantRIVERAIN MEDICAL GROUP
3020 SOUTH TECH BLVD.
MIAMISBURG, OH 45342-4860
PMA NumberP000041
Supplement NumberS006
Date Received07/26/2007
Decision Date08/30/2007
Reclassified Date 02/21/2020
Product Code 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 ProductNo
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.
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