SENOCLAIRE

Digital Breast Tomosynthesis

FDA Premarket Approval P130020 S001

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 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.

• Device: SENOCLAIRE
• Classification Name: Digital Breast Tomosynthesis
• Generic Name: Digital Breast Tomosynthesis
• Applicant: GE Healthcare
• Date Received: 2016-07-19
• Decision Date: 2017-01-05
• PMA: P130020
• Supplement: S001
• 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