Senographe Pristina 3D

Digital Breast Tomosynthesis

FDA Premarket Approval P130020 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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+.

• Device: Senographe Pristina 3D
• Classification Name: Digital Breast Tomosynthesis
• Generic Name: Digital Breast Tomosynthesis
• Applicant: GE Healthcare
• Date Received: 2017-10-26
• Decision Date: 2017-12-28
• PMA: P130020
• Supplement: S003
• Product Code: OTE
• Advisory Committee: Radiology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: GE Healthcare 3000 N. Grandview Blvd waukesha, WI 53188

Supplemental Filings

Supplement Number	Date	Supplement Type
P130020		Original Filing
S004	2020-05-04	Normal 180 Day Track
S003	2017-10-26	Real-time Process
S002	2016-08-12	Normal 180 Day Track
S001	2016-07-19	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00840682100076	P130020	000
00840682100045	P130020	000
00840682120142	P130020	002
00195278194039	P130020	002
00840682142038	P130020	003