Digital Accreditation

Note to MAMMOGRAPHY FACILITY STAFF: To get a quick response to your questions about MQSA or other concerns, call our MQSA Facility Hotline at 1-800-838-7715, rather than submitting your questions by E-Mail.

FDA Approves the American College of Radiology to Accredit the Agfa Computed Radiography (CR) Mammography System

On September 4, 2012, FDA approved the American College of Radiology (ACR) to accredit the Agfa Computed Radiography (CR) Mammography System, effective September 14, 2012. With the availability of accreditation from the States of Arkansas and Texas in Arkansas and Texas, respectively, and from ACR nationwide, FDA will discontinue its Certification Extension Program for this unit on September 14, 2012. Any facility whose accreditation body is the State of Iowa that wants to install and use this unit must apply to ACR for accreditation or wait until the FDA has approved the State of Iowa to accredit this unit.

FDA Approves the State of Arkansas to Accredit Four Full-Field Digital Mammography (FFDM) Units

On July 24, 2012, and effective immediately, FDA approved the State of Arkansas to accredit the following full-field digital mammography (FFDM) units:

• Fuji Aspire HD
• Konica Minolta Xpress Digital Mammography CR System
• Giotto Image 3D/3DL
• Agfa CR Mammography System

With the availability of accreditation nationwide, FDA no longer grants certificate extensions to facilities for the Fuji and the Konica units. Until accreditation of the Giotto or the Agfa unit is available from its accreditation body, any facility whose accreditation body is other than the State of Arkansas or the State of Texas and that wants to install and use the Giotto or Agfa unit must apply to FDA for the Certification Extension Program.

FDA Approves the State of Texas to Accredit Agfa Computed Radiography (CR) Mammography System

On June 8, 2012, and effective immediately, FDA approved the State of Texas to accredit the Agfa Computed Radiography (CR) Mammography System.

FFDM and DBT Systems

FDA approved, cleared, or accepted the following FFDM and DBT units for use in mammography facilities as indicated by date:

• Konica Minolta Xpress Digital Mammography Computed Radiography (CR) System on 12/23/11
• Agfa Computed Radiography (CR) Mammography System on 12/22/11
• Fuji Aspire Computed Radiography for Mammography (CRM) System on 12/8/11
• Giotto Image 3D-3DL Full-Field Digital Mammography (FFDM) System on 10/27/11
• Fuji Aspire HD Full-Field Digital Mammography (FFDM) System on 9/1/11
• GE Senographe Care Full-Field Digital Mammography (FFDM) System on 10/7/11
• Planmed Nuance Excel Full-Field Digital Mammography (FFDM) System on 9/23/11
• Planmed Nuance Full-Field Digital Mammography (FFDM) System on 9/23/11
• Siemens Mammomat Inspiration Pure Full-Field Digital Mammography (FFDM) System on 8/16/11
• Hologic Selenia Encore Full-Field Digital Mammography (FFDM) System on 6/15/11
• Philips (Sectra) MicroDose L30 Full-Field Digital Mammography (FFDM) System on 4/28/11
• Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System on 2/11/11
• Siemens Mammomat Inspiration Full Field Digital Mammography (FFDM) System on 2/11/11
• Carestream Directview Computed Radiography (CR) Mammography System on 11/3/10
• Hologic Selenia Dimensions 2D Full Field Digital Mammography (FFDM) System on 2/11/09
• Hologic Selenia S Full Field Digital Mammography (FFDM) System on 2/11/09
• Siemens Mammomat Novation S Full Field Digital Mammography (FFDM) System on 2/11/09
• Hologic Selenia Full Field Digital Mammography (FFDM) System with a Tungsten target in 11/2007
• Fuji Computed Radiography Mammography Suite (FCRMS) on 07/10/06
• GE Senographe Essential Full Field Digital Mammography (FFDM) System on 04/11/06
• Siemens Mammomat Novation DR Full Field Digital Mammography (FFDM) System on 08/20/04
• GE Senographe DS Full Field Digital Mammography (FFDM) System on 02/19/04
• Lorad/Hologic Selenia Full Field Digital Mammography (FFDM) System on 10/2/02
• Lorad Digital Breast Imager Full Field Digital Mammography (FFDM) System on 03/15/02
• Fischer Imaging SenoScan Full Field Digital Mammography (FFDM) System on 09/25/01
• GE Senographe 2000D Full Field Digital Mammography (FFDM) System on 01/28/00

As of the dates listed below under the heading “FDA-Approved Accreditation Bodies for FFDM Units,” facilities with these FFDM units must apply for accreditation from one of the FDA-approved accreditation bodies (ABs). Thus, FDA no longer accepts applications to extend existing MQSA certification to include these units.

FDA-Approved Accreditation Bodies (ABs) for FFDM or DBT Units

The current ABs approved to accredit FFDM or DBT units are the American College of Radiology (ACR), the State of Arkansas (SAR), the State of Iowa (SIA), and the State of Texas (STX).

Applicants with FFDM or DBT units other than the units listed in the table above must continue to apply to and be approved by the FDA for extension of their certificates to include the use of an FFDM or DBT unit, in order to operate those units legally. Requests for FFDM or DBT certification extension need to include all the information listed in the document MQSA Facility Certification Extension Requirements and should be forwarded to:

FFDM and DBT Certification Extension Program
Division of Mammography Quality Standards
FDA/CDRH/OIR
10903 New Hampshire Ave., WO66-4528
Silver Spring, MD 20993-0002
Phone: 301-796-5919
Fax: 301-847-8502

If you have any questions, please contact the MQSA facility hotline at 1-800-838-7715 or by e-mail at MQSAhotline@hcmsllc.com.