SENOCLAIRE
FDA premarket approval P130020/S001 · decided 2017-01-05
Approval details
- PMA number
- P130020
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOCLAIRE
- Generic name
- Digital breast tomosynthesis
- Applicant
- GE Healthcare
- Date received
- 2016-07-19
- Decision date
- 2017-01-05
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- Approval for GE SenoClaire Digital Breast Tomosynthesis system indicated for acquisition of multiple projection views to produce 3D digital mammography images suitable to be used in screening and diagnosis of breast cancer. A screening examination may consist of a 3D DBT image set consisting of a CC and MLO view, and a 2D synthesized image set consisting of a CC and MLO V-Preview images.
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