Selenia Dimensions 3D System High Resolution Tomosynthesis
FDA premarket approval P080003/S008 · decided 2019-10-24
Approval details
- PMA number
- P080003
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Selenia Dimensions 3D System High Resolution Tomosynthesis
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2019-04-04
- Decision date
- 2019-10-24
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- 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.
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