Medical Devices

MAMMOMAT Inspiration with Tomosynthesis - P140011

Image of the device.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: MAMMOMAT Inspiration with Tomosynthesis Option
PMA Applicant: Siemens Medical Solutions USA, Inc.
Address: 51 Valley Stream Pkwy., Malvern, PA 19355-1406
Approval Date: April 21, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140011a.pdf

What is it? MAMMOMAT Inspiration with Tomosynthesis Option 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 Tomosynthesis Option consists of a software upgrade to the MAMMOMAT Inspiration Full-Field Digital Mammography system, which is FDA-approved for conventional mammography. The upgraded system produces multiple, low-dose x-ray projection images of the breast that are used to create cross-sectional views of the breast, called Digital Breast Tomosynthesis images.

When is it used? The MAMMOMAT Inspiration device with Tomosynthesis Option is used for breast cancer screening and diagnosis.

What will it accomplish? The tomosynthesis images used along with conventional mammogram 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.

Page Last Updated: 05/18/2015
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