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: Selenia Dimensions 3D System
PMA Applicant: Hologic, Inc.
Address: 35 Crosby Dr., Bedford, MA 01730
Approval Date: May 16, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/
p080003s001a.pdf
What is it? The Selenia Dimensions System with the C-View Software Module is a mammography device that provides digital 2D and 3D images for the screening and diagnosis of breast cancer.
How does it work? The Selenia Dimensions 3D System is comprised of hardware and software upgrades to the Selenia Dimensions 2D full-field digital mammography system, which is FDA approved for conventional mammography. The hardware upgrades produces multiple, low-dose x-ray images of the breast; the software upgrade uses the low-dose x-ray images to create cross-sectional (tomosynthesis) views of the breast.
The C-View Software Module is an additional software upgrade that can be used to create a single 2D view from the information obtained from the multiple 3D views of the breast.
When is it used? The Selenia Dimensions System with the C-View Software Module is intended for the same clinical uses as 2D mammography systems for the screening and diagnosis of breast cancer. The physician can select the screening option that is most appropriate for each patient.
What will it accomplish? By generating the 2D and 3D images from a single screening exam, the C-View Software Module can help physicians maximize the benefit of low-dose x-ray imaging for detecting 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.
