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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namedigital breast tomosynthesis
PMA NumberP130020
Date Received07/26/2013
Decision Date08/26/2014
Product Code
OTE[ Registered Establishments with OTE ]
Docket Number 14M-1279
Notice Date 09/02/2014
Advisory Committee Radiology
Clinical Trials NCT00535184
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the senoclaire. This device is indicated for the acquisition of 2d images and also for the acquisition of multiple projection views intended to produce 3d dbt images suitable for screening and diagnosis of breast cancer. Senoclaire can be used for the same clinical applications as traditional mammography for screening mammography. A screening examination will consist of: 1) 2d image set consisting of a craniocaudal view and of a mediolateral oblique view, or 2) a 2d craniocaudal view and 3d mediolateral oblique image set. The senoclaire digital breast tomosynthesis (dbt) option to senographe essential ffdm system may also be used for additional diagnostic workup of the breast.
Approval Order Approval Order