FDA clears ACR to accredit Fuji CR mammo systems

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The Food and Drug Administration (FDA) has approved the ACR (American College of Radiology) to accredit the Fuji FCRm full-field digital mammography (FFDM) system. The approval began yesterday. ACR will now contact facilities using Fuji FCRm systems under an FDA-approved extended MQSA certificate to advise them of this change and how to proceed with accreditation. The organization is instructing facilities to wait until they are contacted to take action for accreditation. Meanwhile, they are permitted to operate during the transition period, ACR said.

FDA said it will no longer accept applications to extend existing MQSA certificates to include the use of Fuji FCRm FFDM systems. The ACR recommends that facilities contact them for details relating to the accreditation process.