This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for modifications to the approved system to permit use of an optional contrast enhancement algorithm (dynamic range management) introduction of new display protocols and minor changes in the display scenarios, and addition of keyboard shortcuts for window width/window level settings. The supplement also includes changes in the labeling to reflect the modifications listed above.
| Device | SENOGRAPHE |
| Classification Name | Full Field Digital, System, X-ray, Mammographic |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GE Healthcare |
| Date Received | 2002-10-03 |
| Decision Date | 2002-11-21 |
| PMA | P990066 |
| Supplement | S015 |
| Product Code | MUE |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GE Healthcare 3000 N. Grandview Blvd waukesha, WI 53188 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990066 | Original Filing | |
| S037 | 2010-06-22 | 135 Review Track For 30-day Notice |
| S036 | 2010-04-27 | 30-day Notice |
| S035 | 2010-01-14 | Normal 180 Day Track |
| S034 | 2009-10-13 | Real-time Process |
| S033 | 2009-05-21 | Real-time Process |
| S032 | 2008-06-30 | Special (immediate Track) |
| S031 | 2008-06-23 | 30-day Notice |
| S030 | 2008-03-26 | Real-time Process |
| S029 | 2007-05-21 | Real-time Process |
| S028 | 2007-02-21 | Real-time Process |
| S027 | 2006-12-11 | Real-time Process |
| S026 | 2006-12-01 | Special (immediate Track) |
| S025 | 2006-09-27 | 30-day Notice |
| S024 | 2006-08-02 | Special (immediate Track) |
| S023 | 2006-04-17 | Special (immediate Track) |
| S022 | 2005-09-13 | Special (immediate Track) |
| S021 | 2005-06-01 | Normal 180 Day Track |
| S020 | 2005-05-03 | Normal 180 Day Track |
| S019 | 2005-04-18 | Real-time Process |
| S018 | ||
| S017 | 2004-04-12 | Normal 180 Day Track No User Fee |
| S016 | 2003-09-02 | Normal 180 Day Track |
| S015 | 2002-10-03 | Normal 180 Day Track |
| S014 | 2002-06-03 | Normal 180 Day Track |
| S013 | 2002-05-13 | 30-day Notice |
| S012 | 2002-03-12 | 30-day Notice |
| S011 | 2002-02-07 | 30-day Notice |
| S010 | 2001-11-16 | Normal 180 Day Track |
| S009 | 2001-11-14 | 135 Review Track For 30-day Notice |
| S008 | 2001-10-26 | Real-time Process |
| S007 | 2001-10-15 | Normal 180 Day Track |
| S006 | 2001-09-04 | 30-day Notice |
| S005 | 2001-08-13 | 30-day Notice |
| S004 | 2001-06-08 | Normal 180 Day Track |
| S003 | 2001-04-04 | Normal 180 Day Track |
| S002 | 2000-12-19 | Normal 180 Day Track |
| S001 | 2000-07-28 | Normal 180 Day Track |