Approval for software option 3dquoromtm technology, which generates thicker 6 mm slices (also referred as smartslices or slabs) and change to the indications for use statement as a result of this update.
Device | Selenia Dimensions 3D System High Resolution Tomosynthesis |
Classification Name | Digital Breast Tomosynthesis |
Generic Name | Digital Breast Tomosynthesis |
Applicant | HOLOGIC, INC. |
Date Received | 2019-04-04 |
Decision Date | 2019-10-24 |
PMA | P080003 |
Supplement | S008 |
Product Code | OTE |
Advisory Committee | Radiology |
Supplement Type | Normal 180 Day Track |
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