This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: SenoClaire
PMA Applicant: General Electric Healthcare
Address: 3000 N. Grandview Blvd., Waukesha, WI 53188
Approval Date: August 26, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130020a.pdf
What is it? SenoClaire is a mammography device that produces 2D digital images as well as multiple cross-sectional images of the breast for the screening and diagnosis of breast cancer.
How does it work? The SenoClaire device consists of hardware and software upgrades to the Senographe Essential 2D full-field digital mammography system, which is FDA-approved for conventional mammography. The hardware upgrade produces multiple, low-dose x-ray projection images of the breast; the software upgrade uses the low-dose x-ray images to create cross-sectional (tomosynthesis) views of the breast.
During a mammogram, each breast is compressed and imaged separately at two different angles. One view is taken above the horizontally compressed breast and the other is taken from the side and at an angle of the diagonally-compressed breast. With SenoClaire the second view can either be a conventional 2D image or a set of tomosynthesis images.
When is it used? The SenoClaire device is used for breast cancer screening and diagnosis.
What will it accomplish? The tomosynthesis images provide additional information to help physicians detect and diagnose breast cancer.
When should it not be used? There are no known contraindications.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.