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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.
 
DeviceASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
Classification Namedigital breast tomosynthesis
Generic Namedigital breast tomosynthesis
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west avenue
stamford, CT 06902-6300
PMA NumberP160031
Date Received08/01/2016
Decision Date01/10/2017
Product Code
OTE[ Registered Establishments with OTE ]
Docket Number 17M-0181
Notice Date 01/12/2017
Advisory Committee Radiology
Clinical Trials NCT02156258
NCT02692209
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 
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