News | December 15, 2011

FDA Approves the ACR to Accredit Planmed Full Field Digital Mammography Systems

December 15, 2011 – The U.S. Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) to accredit the Planmed Nuance and Nuance Excel full-field digital mammography (FFDM) systems beginning Dec. 27, 2011.

The ACR will begin contacting facilities that already use Planmed systems under an FDA-approved extended MQSA certificate to advise them of this change and how to proceed with accreditation. Such facilities need not take any action towards accreditation until they are contacted by the ACR, and are permitted to operate during the transition period.

Beginning December 27, 2011, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of Planmed Nuance and Nuance Excel systems. As of that date, facilities should contact the ACR for information on how to begin the accreditation process.

The following systems must be accredited

  • Carestream DirectView (computed radiography)
  • Fischer Senoscan
  • Fuji FCRm (computed radiography)
  • General Electric Senographe 2000D, DS, Essential, Senographe Care
  • Planmed Nuance and Nuance Excel
  • Lorad Selenia, Selenia S, Selenia Dimensions, Selenia Encore
  • Siemens Mammomat Novation DR, Mammomat Novation S, Mammomat Inspiration, Mammomat Inspiration Pure
  • Philips (Sectra) MicroDose Mammography L30

Applicants with other FFDM systems 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 systems legally.

For more information: www.acr.org

 

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