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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 WEST AVENUE
STAMFORD, CT 06902-6300
PMA NumberP160031
Supplement NumberS003
Date Received07/02/2020
Decision Date09/30/2020
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 1) the integration of the DBT Option as a software module on the 510(k) cleared ASPIRE Bellus II (K171463) for the reconstruction of tomosynthesis acquisitions, and 2) an updated Indications for Use to include the optional integration of the DBT Option software module on the cleared ASPIRE Bellus II and its functionality.
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