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 the following changes in the selenia qc manual: 1) change the minimum scores for the acr phantom test to 5 fibers, 4 specs, and 4 masses form 4 fibers, 4 specs, and 3 masses. 2) change the signal-to-noise test result minimum from 40 to 35. The 40 value was based on the use of the br-12 phantom, whereas the standard phantom is the act with a minimum value of 35. 3) add a specification of 28 k vp and 65 mas for performance of qc testing.
| Device | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | HOLOGIC, INC. |
| Date Received | 2003-03-28 |
| Decision Date | 2003-09-24 |
| PMA | P010025 |
| Supplement | S002 |
| Product Code | MUE |
| Advisory Committee | Radiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 36 Apple Ridge Road danbury, CT 06810 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010025 | Original Filing | |
| S020 | 2010-06-29 | Normal 180 Day Track |
| S019 | 2010-06-01 | Normal 180 Day Track |
| S018 | 2010-02-03 | 30-day Notice |
| S017 | 2009-11-05 | Real-time Process |
| S016 | 2009-04-13 | 30-day Notice |
| S015 | 2009-02-09 | Real-time Process |
| S014 | ||
| S013 | 2008-04-30 | Normal 180 Day Track |
| S012 | 2008-04-01 | Real-time Process |
| S011 | ||
| S010 | 2007-03-12 | Real-time Process |
| S009 | 2006-11-24 | Real-time Process |
| S008 | 2005-10-24 | Normal 180 Day Track |
| S007 | 2005-06-24 | Normal 180 Day Track |
| S006 | ||
| S005 | 2004-05-07 | Normal 180 Day Track |
| S004 | 2003-12-19 | Real-time Process |
| S003 | 2003-04-15 | Normal 180 Day Track |
| S002 | 2003-03-28 | Real-time Process |
| S001 | 2002-03-29 | Normal 180 Day Track |