PMA P130020S002

Device: SENOGRAPHE PRISTINA 3D
Applicant: GE Healthcare
PMA number: P130020
Supplement: S002
Product code: OTE
Decision date: 2017-03-03
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
Approval order 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.

Current openFDA PMA Record#

Device: SENOGRAPHE PRISTINA 3D
Applicant: GE Healthcare
PMA number: P130020
Supplement: S002
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2017-03-03
Decision code: APPR
Date received: 2016-08-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.