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 a 2d mammography system for screening mammograms. Specifically, the selenia dimensions system can be used to generate 2d digital mammograms and 3d mammograms. Each screening examination may consist of: a 2d ffdm image set; or a 2d and 3d image set, where the 2d image can be either a ffdm or a 2d image generated from the 3d image set. The selenia dimensions system may also be used for additional diagnostic workup of the breast.
| Device | SELENIA DIMENSIONS 3D SYSTEM |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | HOLOGIC, INC. |
| Date Received | 2012-10-09 |
| Decision Date | 2013-05-16 |
| Notice Date | 2013-05-23 |
| PMA | P080003 |
| Supplement | S001 |
| Product Code | OTE |
| Docket Number | 13M-0595 |
| Advisory Committee | Radiology |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| 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