ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
FDA premarket approval P160031 · decided 2017-01-10
Approval details
- PMA number
- P160031
- Trade name
- ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
- Generic name
- Digital breast tomosynthesis
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Date received
- 2016-08-01
- Decision date
- 2017-01-10
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Stamford, CT
- Statement
- Approval for the Aspire Cristalle Digital Breast Tomosynthesis Option. The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images, and is intended for use in the screening and diagnosis of breast cancer. A screening examination may consist of sets of CC and MLO images acquired in: 1) the FFDM mode only, or 2) an FFDM image set and a DBT image set acquired in the ST (standard) mode. The FFDM image set and the DBT image set must be acqui
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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 |
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| ASPIRE Cristalle (K173132) | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 |
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| Fujifilm Diathermic Slitter (FlushKnife) (K171096) | Fujifilm Medical Systems U.S.A, Inc. | 2017-05-09 |