The Food and Drug Administration has approved the American College of Radiology (ACR) as the accrediting body for the Lorad Selenia full-field digital mammography (FFDM) system.
Prior to the approval, facilities purchasing the system were required to file directly with the FDA for an extension of their existing Mammography Quality Standards Act (MQSA) certification to include the new system, and were also required to have a film-screen system available at their site. Following the appointment of the ACR as Selenia’s accrediting body, facilities purchasing a Selenia system will go directly to the ACR for accreditation and will no longer be required to have a film-screen system.
The FDA began contacting facilities that have previously installed Selenia systems on September 15 to advise them of the steps needed to gain accreditation for these units, according to the company.
Lorad is a division of Bedford, MA-based digital x-ray and mammography provider Hologic.
By AuntMinnie.com staff writersSeptember 17, 2003
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