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U.S. Department of Health and Human Services

Medical Devices

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Selenia Dimensions 3D System - P080003

Picture of the Selenia Dimensions 3D SystemThis 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:
Hologic, Inc., 35 Crosby Dr., Bedford, MA 01730
Approval Date:
February 11, 2011
Approval Letter:
http://www.accessdata.fda.gov/ cdrh_docs/pdf8/p080003a.pdf

What is it? The Selenia Dimensions System 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 images to create cross-sectional (tomosynthesis) views through the breast.

When is it used? The Selenia Dimensions System is intended for the same clinical uses as 2D mammography systems. The screening examination will consist of a 2D image set or a 2D plus 3D image set.

What will it accomplish? The 3D 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. 

Other Resources: