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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.
 
DeviceMAMMOMAT B.brilliant with Tomosynthesis Option
Generic NameDigital breast tomosynthesis
ApplicantSiemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Malvern, PA 19355-1406
PMA NumberP140011
Supplement NumberS008
Date Received02/29/2024
Decision Date09/23/2024
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 for 1) new reconstruction algorithm called PREMIA, 2) updated image acquisition hardware to enable faster tomosynthesis scan, 3) rebranding the system to MAMMOMAT B.brilliant with Tomosynthesis Option.
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