PMA P080003S008

Device: Selenia Dimensions 3D System High Resolution Tomosynthesis
Applicant: Hologic, Inc.
PMA number: P080003
Supplement: S008
Product code: OTE
Decision date: 2019-10-24
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
Approval order statement: 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.

Current openFDA PMA Record#

Device: Selenia Dimensions 3D System High Resolution Tomosynthesis
Applicant: Hologic, Inc.
PMA number: P080003
Supplement: S008
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2019-10-24
Decision code: APPR
Date received: 2019-04-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: 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.