Devices · GE Healthcare

Senographe Pristina 3D

GE Healthcare is listed for Senographe Pristina 3D (P130020/S005). The FDA list gives November 21, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the PMA pathway. openFDA describes product code OTE as “Digital Breast Tomosynthesis”: To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020S005

Official FDA database record

Date of final decision

November 21, 2025

Company on the FDA list

GE Healthcare

Lead panel

Radiology

Primary product code

OTE

openFDA device name for the code

Digital Breast Tomosynthesis

Device class

3

Regulation number

Not returned

openFDA decision description

Not returned

openFDA decision code

Not returned

Statement or summary label

Not returned