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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.
 
DeviceASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
Generic NameDigital breast tomosynthesis
ApplicantFujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford, CT 06902
PMA NumberP160031
Supplement NumberS004
Date Received11/15/2022
Decision Date02/13/2023
Product Code OTE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the introduction of a higher dose setting (H-mode) for the DBT option.
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