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.

DeviceSenographe Pristina 3D and SenoClaire
Generic NameDigital Breast Tomosynthesis
ApplicantGE Healthcare
Date Received2020-05-04
Decision Date2021-03-23
PMAP130020
SupplementS004
Product CodeOTE 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address GE Healthcare 3000 N. Grandview Blvd waukesha, WI 53188

Supplemental Filings

Supplement NumberDateSupplement Type
P130020Original 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 IDPMASupp
00840682100076 P130020 000
00840682100045 P130020 000
00840682120142 P130020 002
00840682142038 P130020 003

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