Approval for the mammoreader. The mammoreader is a computer system intended to identify and mark regions of interest on standard mammographic views to bring them 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 mammogram that may warrant a second review.
| Device | SECOND LOOK |
| Classification Name | Analyzer, Medical Image |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD, INC. |
| Date Received | 2001-07-19 |
| Decision Date | 2002-01-15 |
| Notice Date | 2002-01-22 |
| PMA | P010038 |
| Supplement | S |
| Product Code | MYN |
| Docket Number | 02M-0030 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ICAD, INC. 98 Spit Brook Road suite 100 nashua, NH 03062 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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