|Classification Name||digital breast tomosynthesis|
|Docket Number|| 14M-1279|
|Notice Date|| 09/02/2014|
|Expedited Review Granted?|| No|
||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.