Approval for use of the 3. 9. 3. 7 version of the software. The new software is intended to improve the overall sensitivity, improve the breast segmentation process, reduce the false marker rate and improve the overall consistency of the algorithm. The clinical performance claims are not changed.
| Device | ICAD |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD, INC. |
| Date Received | 2002-10-28 |
| Decision Date | 2003-02-24 |
| PMA | P010038 |
| 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 | ICAD, INC. 98 Spit Brook Road suite 100 nashua, NH 03062 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010038 | | Original Filing |
| S017 |
2012-10-05 |
Normal 180 Day Track |
| S016 |
2012-08-10 |
Normal 180 Day Track |
| S015 |
2008-05-19 |
Normal 180 Day Track No User Fee |
| S014 |
2007-04-02 |
Normal 180 Day Track No User Fee |
| S013 |
2006-12-18 |
Normal 180 Day Track |
| S012 |
2006-07-12 |
Normal 180 Day Track |
| S011 | | |
| S010 |
2005-10-18 |
Normal 180 Day Track No User Fee |
| S009 |
2005-01-18 |
Normal 180 Day Track No User Fee |
| S008 |
2004-06-24 |
Normal 180 Day Track |
| S007 |
2004-04-28 |
Real-time Process |
| S006 |
2004-04-26 |
Normal 180 Day Track No User Fee |
| S005 |
2003-07-29 |
Normal 180 Day Track |
| S004 |
2003-06-18 |
Normal 180 Day Track |
| S003 |
2003-02-10 |
Normal 180 Day Track |
| S002 |
2002-10-28 |
Real-time Process |
| S001 |
2002-10-28 |
Normal 180 Day Track |
NIH GUDID Devices