Approval for a change to the selenia dimensions/3dimensions detector subsystem for approval of a new application specific integrated circuit (asic), and also the necessary changes to some of the detector pcb hardware, detector embedded software and detector firmware in order to support dual sourcing.
| Device | Selenia Dimensions / 3Dimensions |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | HOLOGIC, INC. |
| Date Received | 2018-05-02 |
| Decision Date | 2018-06-22 |
| PMA | P080003 |
| Supplement | S007 |
| Product Code | OTE |
| Advisory Committee | Radiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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