PMA P160031
- 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
- 2023-02-13
- Generic name
- Digital breast tomosynthesis
- Approval order statement
- Approval for the introduction of a higher dose setting (H-mode) for the DBT option.
Current openFDA PMA Record#
- Device
- ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- PMA number
- P160031
- Supplement
- S004
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2023-02-13
- Decision code
- APPR
- Date received
- 2022-11-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the introduction of a higher dose setting (H-mode) for the DBT option.