ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
FDA premarket approval P160031/S003 · decided 2020-09-30
Approval details
- PMA number
- P160031
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
- Generic name
- Digital breast tomosynthesis
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Date received
- 2020-07-02
- Decision date
- 2020-09-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Stamford, CT
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FUJIFILM Bronchoscope Model EB-530P (K171291) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-19 |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 |
| ASPIRE Cristalle (K173132) | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 |
| ASPIRE Bellus II (K171463) | Fujifilm Medical Systems U.S.A, Inc. | 2017-09-29 |
| Fujifilm Duodenoscope Model ED-530XT (K152257) | Fujifilm Medical Systems U.S.A, Inc. | 2017-07-21 |
| Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (K163624) | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-30 |
| FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (K162749) | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-15 |
| Fujifilm Diathermic Slitter (FlushKnife) (K171096) | Fujifilm Medical Systems U.S.A, Inc. | 2017-05-09 |