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 changing the oem components (detector and image processing) developed by lorad, the mammomat novation, to an ffdm system that is designed solely from components designed or specified by siemens, the mammomat inspiration.
| Device | SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTION |
| Date Received | 2009-10-13 |
| Decision Date | 2010-11-05 |
| PMA | P030010 |
| Supplement | S006 |
| 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 | SIEMENS MEDICAL SOLUTION 51 Valley Stream Pkwy. malvern, PA 19355 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030010 | Original Filing | |
| S006 | 2009-10-13 | Normal 180 Day Track |
| S005 | 2009-07-22 | Normal 180 Day Track |
| S004 | 2009-05-18 | Special (immediate Track) |
| S003 | 2005-10-26 | Real-time Process |
| S002 | 2005-05-20 | Special (immediate Track) |
| S001 | 2005-01-19 | Normal 180 Day Track |