Senographe Pristina 3D and SenoClaire

FDA Premarket Approval P130020 S004

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 of the algorithm updates of the synthetized 2d image called v-preview for the senographe pristina 3d and senoclaire.

• Device: Senographe Pristina 3D and SenoClaire
• Generic Name: Digital Breast Tomosynthesis
• Applicant: GE Healthcare
• Date Received: 2020-05-04
• Decision Date: 2021-03-23
• PMA: P130020
• Supplement: S004
• Product Code: OTE
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• 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