| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION |
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| Generic Name | digital breast tomosynthesis |
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| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west avenue
stamford, CT 06902-6300 |
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| PMA Number | P160031 |
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| Date Received | 08/01/2016 |
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| Decision Date | 01/10/2017 |
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| Product Code |
OTE |
| Docket Number | 17M-0181 |
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| Notice Date | 01/12/2017 |
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| Advisory Committee |
Radiology |
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| Clinical Trials | NCT02156258
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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 acquired with N-mode dose setting, and may be acquired in one compression (Tomo Set mode) or separate compressions (FFDM and DBT modes). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S003 S004 |
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