ONGUARD
FDA premarket approval P000041/S006 · decided 2007-08-30
Approval details
- PMA number
- P000041
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ONGUARD
- Generic name
- Analyzer, medical image
- Applicant
- Riverain Medical Group
- Date received
- 2007-07-26
- Decision date
- 2007-08-30
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Miamisburg, OH
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SOFTVIEW, MODEL 2.01 (K092363) | Riverain Medical Group | 2010-03-18 |