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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 Option
Generic NameDigital breast tomosynthesis
ApplicantFujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford, CT 06902
PMA NumberP160031
Supplement NumberS002
Date Received04/29/2019
Decision Date10/25/2019
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 changing the image processing in DBT reconstruction to Iterative Super-Resolution Reconstruction (ISR) and applying new image processing, Dynamic Visualization II for mammography (DVIIm), to the DBT and the FFDM images.
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