SENOGRAPHE PRISTINA 3D
FDA premarket approval P130020/S002 · decided 2017-03-03
Approval details
- PMA number
- P130020
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOGRAPHE PRISTINA 3D
- Generic name
- Digital breast tomosynthesis
- Applicant
- GE Healthcare
- Date received
- 2016-08-12
- Decision date
- 2017-03-03
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- Approval for GE Senographe Pristina 3D 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. Senographe Pristina 3D uses similar DBT technology as SenoClaire and consists of a software and hardware upgrade option that enables the acquisition of projection images of the breast in order to reconstruct tomosynthesis images.
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