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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 Breast Tomosynthesis System
Generic NameDigital breast tomosynthesis
ApplicantFujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford, CT 06902
PMA NumberP160031
Supplement NumberS001
Date Received10/23/2018
Decision Date02/08/2019
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 the implementation of the synthesized 2D (S-View) image, changing the image processing in DBT reconstruction to iterative super-resolution reconstruction (ISR), applying new image processing, Dynamic Visualization II for mammography (DVIIm), to DBT and synthesized 2D images, and related changes in the indications for use (IFU).
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