FDA Approves the ACR to Accredit iCRco CR Full-Field Digital Systems
The Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) to accredit the iCRco full field digital mammography (FFDM) systems beginning February 3, 2015.
The following systems must be accredited:
Agfa Computed Radiography
Carestream DirectView (computed radiography)
Fischer Senoscan
Fuji FCRm, Aspire CR (computed radiography)
Fuji Aspire HD (FDR), Aspire HD Plus, Aspire HD-S
General Electric Senographe 2000D, DS, Essential, Senographe Care
Giotto 3D – 3DL
iCRco CR
Konica Minolta Xpress (computed radiography)
Lorad Selenia, Selenia S, Selenia Dimensions, Selenia Encore
Philips (Sectra) MicroDose Mammography L30
Planmed Nuance, Nuance Excel
Siemens Mammomat Novation DR, Mammomat Novation S, Mammomat Inspiration, Mammomat Inspiration Pure
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 Mammography Accreditation Program at (800) 227-6440.
Source: American College of Radiology - Category: Radiology Source Type: news