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. |
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Device | ONGUARD |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | RIVERAIN MEDICAL GROUP 3020 SOUTH TECH BLVD. MIAMISBURG, OH 45342-4860 |
PMA Number | P000041 |
Supplement Number | S006 |
Date Received | 07/26/2007 |
Decision Date | 08/30/2007 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 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. |
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