Approval for the use of the secondlook digital computer-aided detection system for mammography with fuji medical systems computed radiography mammograms (crm). The device is intended to identify and mark regions of interest on screening and diagnostic mammograms from fujifilm medical systems computed radiography system (fuji crm) to bring them to the attention of the radiologist after an initial reading has been completed.
| Device | SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM |
| Classification Name | Analyzer, Medical Image |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD, INC. |
| Date Received | 2006-07-12 |
| Decision Date | 2008-04-04 |
| PMA | P010038 |
| Supplement | S012 |
| 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