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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 and SenoClaire
Generic NameDigital breast tomosynthesis
ApplicantGE Healthcare
3000 N. Grandview Blvd.
Waukesha, WI 53188
PMA NumberP130020
Supplement NumberS004
Date Received05/04/2020
Decision Date03/23/2021
Product Code OTE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the algorithm updates of the Synthetized 2D image called V-Preview for the Senographe Pristina 3D and SenoClaire.
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