Selenia Dimensions / 3Dimensions
FDA premarket approval P080003/S007 · decided 2018-06-22
Approval details
- PMA number
- P080003
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Selenia Dimensions / 3Dimensions
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2018-05-02
- Decision date
- 2018-06-22
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- 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.
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