PMA P130020S003

Device: Senographe Pristina 3D
Applicant: GE Healthcare
PMA number: P130020
Supplement: S003
Product code: OTE
Decision date: 2017-12-28
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
Approval order statement: Approval for a change to Senographe Pristina 3D to add a new Digital Breast Tomosynthesis (DBT) Automatic Optimization of Parameters (AOP) table, called 3D STD+. This new AOP table enables the acquisition of DBT datasets at a dose equivalent to 2D STD+, already enabled on Senographe Pristina for 2D examination. As in 2D, the user will be able to choose which AOP table to use for 3D acquisitions: 3D STD or 3D STD+.

Current openFDA PMA Record#

Device: Senographe Pristina 3D
Applicant: GE Healthcare
PMA number: P130020
Supplement: S003
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2017-12-28
Decision code: APPR
Date received: 2017-10-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to Senographe Pristina 3D to add a new Digital Breast Tomosynthesis (DBT) Automatic Optimization of Parameters (AOP) table, called 3D STD+. This new AOP table enables the acquisition of DBT datasets at a dose equivalent to 2D STD+, already enabled on Senographe Pristina for 2D examination. As in 2D, the user will be able to choose which AOP table to use for 3D acquisitions: 3D STD or 3D STD+.