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New Device Approval

Siemens Mammomat Novation ^DR Full Field Digital Mammography System - PMA P030010

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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Applicant: Siemens MedicalSolutions USA, Inc.
Address: 51 Valley Stream Parkway Malvern , PA 19355
Approval Date: August 20, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf3/P030010a.pdf

What is it? Like regular mammography, digital mammography produces pictures of the breast using X-rays. Instead of film, this process uses detectors that change the X-rays into electrical signals, which are then converted to an image. Digital mammography is used for both screening and diagnosis. For the patient, the procedure is the same as with ordinary mammography. The Siemens Mammomat Novation ^DR Full Field Digital Mammography System (Novation ^DR) is used with an approved X-ray system, the Siemens Mammomat 3000 Nova mammography system, which was cleared by the FDA.

 How does it work? The device passes X-rays through the breast tissue to the digital receptor which converts the X-ray energy to numbers, processes the numbers, and produces an image that can be viewed at a work station or sent to a film printer.

 When is it used? The device is used to screen and diagnose breast cancer just as regular analog (film) mammography.

 What will it accomplish? The Novation ^DR System has been shown to be effective in the detection of breast cancer and other abnormalities.  

When should it not be used? For women who need mammographic screening or diagnosis, there there are no contraindications for this device.  

Additional information: Summary of Safety and Effectiveness Data and labeling are available at: http://www.fda.gov/cdrh/pdf3/p030010.html

Other:

• Questions Consumers Frequently Ask About Digital Mammography: http://www.fda.gov/cdrh/mammography/dig-faq.html#digital
• General Consumer Information on Mammography: http://www.fda.gov/cdrh/mammography/consumers-rev.html
• Interactive tutorial on mammography: http://www.nlm.nih.gov/medlineplus/tutorials/mammography.html
• “Take time to care” fact sheet on mammography: http://www.fda.gov/womens/getthefacts/pdfs/mammography.pdf

Updated October 8, 2004

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