ASPIRE CRISTALLE
FDA 510(k) clearance K133972 · decided 2014-03-25
Clearance details
- K-number
- K133972
- Device name
- ASPIRE CRISTALLE
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-26
- Decision date
- 2014-03-25
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- MUE
- Device class
- 2
- Regulation number
- 892.1715
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Stamford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography System recall (Z-0386-2018) | Fujifilm Medical Systems U.S.A., Inc. | 2018-01-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S004) | Fujifilm Medical Systems U.S.A, Inc. | 2023-02-13 |
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S003) | Fujifilm Medical Systems U.S.A, Inc. | 2020-09-30 |
| Aspire Cristalle Digital Breast Tomosynthesis Option (P160031/S002) | Fujifilm Medical Systems U.S.A, Inc. | 2019-10-25 |
| ASPIRE Cristalle Breast Tomosynthesis System (P160031/S001) | Fujifilm Medical Systems U.S.A, Inc. | 2019-02-08 |
| ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION (P160031) | Fujifilm Medical Systems U.S.A, Inc. | 2017-01-10 |