PMA P000041S006

Device: ONGUARD
Applicant: Riverain Medical Group
PMA number: P000041
Supplement: S006
Product code: MYN
Decision date: 2007-08-30
Generic name: Analyzer, medical image
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.

Current openFDA PMA Record#

Device: ONGUARD
Applicant: Riverain Medical Group
PMA number: P000041
Supplement: S006
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2007-08-30
Decision code: APPR
Date received: 2007-07-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.