Approval for the selenia dimensions 3d system. This device is indicated to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. The selenia dimensions (2d or 3d) system is intended for use in the same clinical applications as 2d mammography systems for screening mammograms. Specifically, the selenia dimensions system can be used to acquire 2d digital mammograms and 3d mammograms. The screening examination will consist of a 2d image set or a 2d and 3d image set. The selenia dimensions system may also be used for additional diagnostic workup of the breast.
| Device | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | HOLOGIC, INC. |
| Date Received | 2008-01-22 |
| Decision Date | 2011-02-11 |
| Notice Date | 2011-03-09 |
| PMA | P080003 |
| Supplement | S |
| Product Code | OTE |
| Docket Number | 11M-0131 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080003 | | Original Filing |
| S008 |
2019-04-04 |
Normal 180 Day Track |
| S007 |
2018-05-02 |
Real-time Process |
| S006 |
2017-09-15 |
Normal 180 Day Track |
| S005 |
2017-05-02 |
Special (immediate Track) |
| S004 |
2017-03-30 |
Special (immediate Track) |
| S003 |
2016-03-30 |
Normal 180 Day Track |
| S002 | | |
| S001 |
2012-10-09 |
Panel Track |
NIH GUDID Devices