PMA P130020S001

Device: SENOCLAIRE
Applicant: GE Healthcare
PMA number: P130020
Supplement: S001
Product code: OTE
Decision date: 2017-01-05
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
Approval order 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.

Current openFDA PMA Record#

Device: SENOCLAIRE
Applicant: GE Healthcare
PMA number: P130020
Supplement: S001
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2017-01-05
Decision code: APPR
Date received: 2016-07-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.