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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.
 
DeviceSenographe Pristina 3D
Generic NameDigital breast tomosynthesis
ApplicantGE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188
PMA NumberP130020
Supplement NumberS003
Date Received10/26/2017
Decision Date12/28/2017
Product Code OTE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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+.
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