RESTON, Va., October 10, 2005 - The Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) to accredit Siemens Mammomat Novation DR full-field digital mammography (FFDM) units beginning October 15, 2005.

On that date, the ACR will begin contacting facilities that have already received FDA approval extending their MQSA certificates to include the use of a Siemens Mammomat Novation DR unit to advise them of the steps to take to achieve accreditation. Such facilities need not take any action towards accreditation until they are contacted by the ACR, and can continue to operate during the transitional period.

As of October 15, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of Siemens Mammomat Novation DR FFDM units. As of that date, all new applicants with these types of Siemens units must contact the ACR and apply for the accreditation of these units.

Applicants with FFDM units other than the GE Senographe 2000D, GE Senographe DS, Fischer SenoScan, Lorad Selenia, and Siemens Mammomat Novation DR must continue to apply to and be approved by the FDA for extension of their certificates to include the use of an FFDM unit, in order to operate those units legally.

For more information, please contact the ACR at (800) 227-6440.

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The ACR is a national professional organization serving more than 32,000 diagnostic radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and medical physicists, with programs focusing on the practice of radiology and the delivery of comprehensive health care services.

Headquarters Office: 1891 Preston White Dr, Reston, VA 20191, (703) 648-8900

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