Radiation-Emitting Products

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.


Applicants with FFDM or DBT units other than the units listed in the table below 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


Accreditation/Certification Options for Facilities Utilizing a 3D System with either 2D FFDM Images or 2D Images Generated from the 3D Image Set (i.e., 2D Synthesized Images)

Currently, the FDA-approved accreditation bodies are not prepared to accredit 3D tomography, as standards have not been developed for this imaging modality. This situation is similar to when FDA approved FFDM for marketing, but the accreditation bodies had not yet developed standards and could not accredit FFDM when it first came on the market. FDA developed the certificate extension program to cover situations where a mammography device has been approved for marketing but where accreditation standards have not yet been established. The certificate extension program that is currently in effect so that facilities can legally use 3D tomography requires that an FDA-approved accreditation body accredit the 2D imaging component of the 3D tomography unit.

For MQSA facilities utilizing a 3D system in clinical practice, your accreditation/certification options are as follows:

  • If your facility’s practice routinely utilizes 3D imaging with acquired 2D FFDM images, then you may submit those 2D FFDM images to your accreditation body for accreditation of the 2D component of your unit.
  • If your facility’s practice routinely utilizes 3D imaging with 2D images generated from the 3D image set (i.e., synthesized 2D images), then you may submit those synthesized 2D images to your accreditation body for accreditation of the 2D component of your unit.

Please contact your accreditation body for information on the submission of images.

You must accredit the 2D portion of your tomography unit with your accreditation body, as that is the only mechanism FDA has for extending your certificate. You should apply to the FDA for certificate extension for the 3D component by visiting FDA’s MQSA web site.

FFDM and DBT Systems

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

  • GE SenoClaire Digital Breast Tomosynthesis (DBT) System on 8/26/14
  • Fuji Aspire Cristalle Full-Field Digital Mammography (FFDM) System on 03/25/14
  • Siemens Mammomat Inspiration Prime Full-Field Digital Mammography (FFDM) System on 06/11/13
  • iCRco 3600M Mammography Computed Radiography (CR) System on 04/26/13
  • Philips MicroDose SI Model L50 Full-Field Digital Mammography (FFDM) System on 02/01/13
  • Fuji Aspire HD Plus Full-Field Digital Mammography (FFDM) System on 09/21/12
  • Fuji Aspire HD-s Full-Field Digital Mammography (FFDM) System on 09/21/12
  • 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).

 
Full Field Digital Mammography (FFDM) or
Digital Breast Tomosynthesis (DBT) Unit
Accreditation Body
Approval Date
Effective Date
 
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 (Molybdenum target)
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 DR
10/07/05
10/15/05
08/26/08
08/26/08
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
Hologic Selenia (Tungsten target)
02/01/08
02/01/08
02/01/08
02/01/08
02/01/08
02/01/08
02/01/08
02/01/08
Siemens Mammomat Novation S
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
Hologic Selenia S
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
Hologic Selenia Dimensions 2D
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
02/11/09
Carestream Directview Computed
Radiography (CR) Mammography
02/08/11
02/16/11
01/07/11
01/07/11
01/07/11
01/07/11
02/08/11
02/08/11
Siemens Mammomat Inspiration
02/11/11
02/11/11
02/11/11
02/11/11
02/11/11
02/11/11
02/11/11
02/11/11
Hologic Selenia Encore
06/15/11
06/15/11
06/15/11
06/15/11
06/15/11
06/15/11
06/15/11
06/15/11
Philips (Sectra) MicroDose L30
10/20/11
10/21/11
07/18/11
07/18/11
 
08/03/11
08/03/11
Siemens Mammomat Inspiration Pure
08/23/11
08/23/11
08/23/11
08/23/11
08/23/11
08/23/11
08/23/11
08/23/11
GE Senographe Care
10/07/11
10/07/11
10/07/11
10/07/11
10/07/11
10/07/11
10/07/11
10/07/11
Planmed Nuance
12/13/11
12/27/11
12/20/11
12/20/11

 
01/20/12
01/20/12
Planmed Nuance Excel
12/13/11
12/27/11
12/20/11
12/20/11

 
01/20/12
01/20/12
Fuji Aspire Computed Radiography for Mammography
01/20/12
01/20/12
01/20/12
01/20/12
01/20/12
01/20/12
01/20/12
01/20/12
Giotto Image 3D/3DL
11/02/12
11/02/12
7/24/12
7/24/12
 
03/09/12
03/09/12
Fuji Aspire HD
03/28/12
04/10/12
7/24/12
7/24/12
05/25/12
05/25/12
03/28/12
04/10/12
Konica Minolta Xpress Digital Mammography CR System
04/19/12
04/27/12
7/24/12
7/24/12
 
04/19/12
04/27/12
Agfa CR Mammography System
09/04/12
09/14/12
7/24/12
7/24/12
 
06/08/12
06/08/12
Fuji Aspire HD-s
06/25/13
06/25/13
06/25/13
06/25/13
 06/25/13
06/25/13
06/25/13
06/25/13
Fuji Aspire HD Plus
06/25/13
06/25/13
06/25/13
06/25/13
06/25/13
06/25/13
06/25/13
06/25/13
Siemens Mammomat Inspiration Prime
07/11/13
07/11/13
07/11/13
07/11/13
 07/11/13
07/11/13
07/11/13
07/11/13
Philips MicroDose SI L50
09/23/13
09/23/13
09/23/13
09/23/13
09/23/13
09/23/13
09/23/13
09/23/13
Siemens Mammomat Inspiration ECO
11/20/13
11/20/13
11/20/13
11/20/13
11/20/13
11/20/13
11/20/13
11/20/13
Fuji Aspire Cristalle
 
10/21/14
10/21/14
10/21/14
10/21/14
10/21/14
10/21/14
10/21/14
10/21/14

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