PMA P160031S002

Device: Aspire Cristalle Digital Breast Tomosynthesis Option
Applicant: Fujifilm Medical Systems U.S.A, Inc.
PMA number: P160031
Supplement: S002
Product code: OTE
Decision date: 2019-10-25
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
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.

Current openFDA PMA Record#

Device: Aspire Cristalle Digital Breast Tomosynthesis Option
Applicant: Fujifilm Medical Systems U.S.A, Inc.
PMA number: P160031
Supplement: S002
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2019-10-25
Decision code: APPR
Date received: 2019-04-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.