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.
| Device | ONGUARD |
| Generic Name | Analyzer, Medical Image |
| Applicant | RIVERAIN MEDICAL GROUP |
| Date Received | 2007-07-26 |
| Decision Date | 2007-08-30 |
| PMA | P000041 |
| Supplement | S006 |
| 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 | No |
| Combination Product | No |
| Applicant Address | RIVERAIN MEDICAL GROUP 3020 South Tech Blvd. miamisburg, OH 45342-4860 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000041 | | Original Filing |
| S011 |
2012-02-14 |
Normal 180 Day Track No User Fee |
| S010 |
2011-09-02 |
Normal 180 Day Track |
| S009 |
2009-12-10 |
Normal 180 Day Track |
| S008 | | |
| S007 | | |
| S006 |
2007-07-26 |
Normal 180 Day Track No User Fee |
| S005 |
2006-07-05 |
Normal 180 Day Track |
| S004 | | |
| S003 |
2005-11-18 |
Normal 180 Day Track No User Fee |
| S002 |
2003-07-10 |
Normal 180 Day Track No User Fee |
| S001 |
2003-02-13 |
Normal 180 Day Track |
NIH GUDID Devices