FDA Approves the ACR to Accredit Fuji Computed Radiography for Mammography Systems - 11/14/2006
The Food and Drug Administration (FDA) has approved the ACR to accredit the Fuji FCRm full-field digital mammography (FFDM) system beginning November 15, 2006.
On that date, the ACR will begin contacting facilities which already use Fuji FCRm 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 November 15, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of Fuji FCRm FFDM systems. As of that date, those Fuji systems must be accredited. Facilities should contact the ACR for information on how to begin the accreditation process.
The following systems must be accredited:
- GE Senographe 2000
- GE Senographe DS
- GE Senographe Essential
- Fischer SenoScan
- Lorad Selenia
- Siemens Mammomat Novation DR and
- Fuji FCRm
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, please contact the ACR at (800) 227-6440.
