Approval for a change in the mammography film digitizer from the formerly approved multirad 860 to the fulcrum.
| Device | ICAD SYSTEM |
| Generic Name | Analyzer, Medical Image |
| Applicant | ICAD, INC. |
| Date Received | 2003-06-18 |
| Decision Date | 2003-10-10 |
| PMA | P010038 |
| Supplement | S004 |
| 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