Approval for a change to the physician labeling of the selenia dimensions 3d system and the selenia dimensions 3d system with c-view software module, to claim superior screening accuracy of 3d plus 2d imaging, where the 2d image can be either a synthesized 2d or a full field digital mammography (ffdm) image, as compared to ffdm alone, for women with dense breasts.
| Device | Selenia Dimensions 3D System. |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | HOLOGIC, INC. |
| Date Received | 2017-05-02 |
| Decision Date | 2017-05-23 |
| PMA | P080003 |
| Supplement | S005 |
| Product Code | OTE |
| Advisory Committee | Radiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730 |
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