PMA P130020S004
- Device
- Senographe Pristina 3D and SenoClaire
- Applicant
- GE Healthcare
- PMA number
- P130020
- Supplement
- S004
- Product code
- OTE
- Decision date
- 2021-03-23
- Generic name
- Digital breast tomosynthesis
- Approval order statement
- Approval of the algorithm updates of the Synthetized 2D image called V-Preview for the Senographe Pristina 3D and SenoClaire.
Current openFDA PMA Record#
- Device
- Senographe Pristina 3D and SenoClaire
- Applicant
- GE Healthcare
- PMA number
- P130020
- Supplement
- S004
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2021-03-23
- Decision code
- APPR
- Date received
- 2020-05-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of the algorithm updates of the Synthetized 2D image called V-Preview for the Senographe Pristina 3D and SenoClaire.