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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 NumberS005
Date Received04/21/2025
Decision Date11/21/2025
Product Code OTE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Senographe Pristina 3D that includes an update to the DBT reconstruction algorithm to enhance image quality using deep learning algorithms to correct sparse view artifacts, compensate for patient motion artifacts and enhance the visibility of soft tissue lesions within the 2D synthetic image.
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