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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 Approved Full Field Digital Mammography Systems (FFDM)

FDA approved the following FFDM units for use in mammography facilities as indicated by date:

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. Thus, FDA no longer accepts applications to extend existing MQSA certification to include these units.

FDA Approved Accreditation Bodies for FFDM Units

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

  Accreditation Body
Approval Date
Effective Date
Full Field Digital Mammography (FFDM) Unit ACR SAR SIA STX
GE Senographe 2000D 12/18/02
02/15/03 		08/15/06
08/15/06 		08/28/03
10/01/03 		05/21/04
05/21/04
Fischer Imaging SenoScan 07/24/03
08/15/03 		    05/21/04
05/21/04
Lorad/Hologic Selenia 09/02/03
09/15/03 		08/15/06
08/15/06 		08/28/03
10/01/03 		05/21/04
05/21/04
GE Senographe DS 08/12/04
09/15/04 		08/15/06
08/15/06 		01/12/06
01/17/06 		08/12/04
09/15/04
Siemens Mammomat Novation 10/07/05
10/15/05 		  01/26/06
02/01/06 		06/29/06
06/29/06
GE Senographe Essential 06/29/06
07/15/06 		08/15/06
08/15/06 		08/24/06
08/24/06 		09/05/06
09/05/06
Fuji Computed Radiography for Mammography 11/13/06
11/15/06 		10/12/06
10/12/06 		11/13/06
11/13/06 		11/13/06
11/13/06

Applicants with FFDM 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 unit, in order to operate those units legally. Requests for FFDM certification extension need to include all the information listed in the document MQSA Facility Certification Requirements for Use of Full Field Digital Mammography (FFDM) and should be forwarded to:

FFDM Certification Extension Program
Division of Mammography Quality and Radiation Programs
FDA/CDRH/OCER
1350 Piccard Drive, HFZ-240
Rockville, MD 20850
Phone: 240-276-3332
Fax: 240-276-3272

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

Updated January 28, 2008

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