PMA P160031S001

Device: ASPIRE Cristalle Breast Tomosynthesis System
Applicant: Fujifilm Medical Systems U.S.A, Inc.
PMA number: P160031
Supplement: S001
Product code: OTE
Decision date: 2019-02-08
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
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).

Current openFDA PMA Record#

Device: ASPIRE Cristalle Breast Tomosynthesis System
Applicant: Fujifilm Medical Systems U.S.A, Inc.
PMA number: P160031
Supplement: S001
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2019-02-08
Decision code: APPR
Date received: 2018-10-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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).