Approval for the addition of the ability of the rapidscreen rs-2000d to process digital images in addition to film/screen images. The device, as modified, will be marketed under the trade name rapidscreen rs-2000d and is indicated for: the rs-2000d is a computer-aided detection (cad) system intended to identify and mark regions of interest (rois) on digital or digitalized frontal chest radiographs. It identifies features associated with solitary pulmonary nodules from 9 to 30 mm in size, which could represent early-stage lung cancer. The device is intended for the use as an aid only after the physician has performed an initial interpretation of the radiograph.
| Device | RAPIDSCREEN RS-2000D |
| Generic Name | Analyzer, Medical Image |
| Applicant | RIVERAIN MEDICAL GROUP |
| Date Received | 2003-02-13 |
| Decision Date | 2003-06-30 |
| PMA | P000041 |
| Supplement | S001 |
| Product Code | MYN |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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