PMA P130020S005

Device: Senographe Pristina 3D
Applicant: GE Healthcare
Product code: OTE
Decision date: 2025-11-21
Generic name: Digital breast tomosynthesis
Approval order statement: Approval for Senographe Pristina 3D that includes an update to the DBT reconstruction algorithm to enhance image quality using deep learning algorithms to correct sparse view artifacts, compensate for patient motion artifacts and enhance the visibility of soft tissue lesions within the 2D synthetic image.

Current openFDA PMA Record

Device: Senographe Pristina 3D
Applicant: GE Healthcare
PMA number: P130020
Supplement: S005
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2025-11-21
Decision code: APPR
Date received: 2025-04-21
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for Senographe Pristina 3D that includes an update to the DBT reconstruction algorithm to enhance image quality using deep learning algorithms to correct sparse view artifacts, compensate for patient motion artifacts and enhance the visibility of soft tissue lesions within the 2D synthetic image.