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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Generic Namedigital breast tomosynthesis
419 west avenue
stamford, CT 06902-6300
PMA NumberP160031
Date Received08/01/2016
Decision Date01/10/2017
Product Code OTE 
Docket Number 17M-0181
Notice Date 01/12/2017
Advisory Committee Radiology
Clinical TrialsNCT02156258
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Supplements:  S001 S002 S003 S004