PMA P160031S003

Device: ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
Applicant: Fujifilm Medical Systems U.S.A, Inc.
PMA number: P160031
Supplement: S003
Product code: OTE
Decision date: 2020-09-30
Generic name: Digital breast tomosynthesis
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.

Current openFDA PMA Record#

Device: ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
Applicant: Fujifilm Medical Systems U.S.A, Inc.
PMA number: P160031
Supplement: S003
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2020-09-30
Decision code: APPR
Date received: 2020-07-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.