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 acquired with n-mode dose setting, and may be acquired in one compression (tomo set mode) or separate compressions (ffdm and dbt modes).
| Device | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| Date Received | 2016-08-01 |
| Decision Date | 2017-01-10 |
| Notice Date | 2017-01-12 |
| PMA | P160031 |
| Supplement | S |
| Product Code | OTE |
| Docket Number | 17M-0181 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 West Avenue stamford, CT 06902-6300 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160031 | | Original Filing |
| S003 |
2020-07-02 |
Real-time Process |
| S002 |
2019-04-29 |
Normal 180 Day Track |
| S001 |
2018-10-23 |
Normal 180 Day Track |
NIH GUDID Devices