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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
Generic NameDigital breast tomosynthesis
ApplicantGE Healthcare
PMA NumberP130020
Supplement NumberS002
Date Received08/12/2016
Decision Date03/03/2017
Product Code OTE 
Advisory Committee Radiology
Clinical TrialsNCT00535184
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for GE Senographe Pristina 3D 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. Senographe Pristina 3D uses similar DBT technology as SenoClaire and consists of a software and hardware upgrade option that enables the acquisition of projection images of the breast in order to reconstruct tomosynthesis images.