Envision Mammography Platform
FDA premarket approval P080003/S009 · decided 2024-07-05
Approval details
- PMA number
- P080003
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Envision Mammography Platform
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2023-08-31
- Decision date
- 2024-07-05
- Days to decision
- 309 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for introduction of Envision Mammography Platform that include updated gantry with adjustable tilted C-Arm, detector electronics, user interfaces, anti-scatter grid, dynamic collimator, and introduction of X-ray source with moving focal spot.
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