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 and should be submitted electronically at DBTelectronicsubmission@fda.hhs.gov or hardcopies forwarded to:

FFDM and DBT Certification Extension Program
Division of Mammography Quality Standards
FDA/CDRH/OIR
10903 New Hampshire Ave., WO66-4456
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 the DBT Certification Extension Requirements page.

For answers to commonly asked questions regarding new modality training for DBT systems, please see our page Frequently Asked Questions about DBT and MQSA.

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 Senographe Pristina with Digital Breast Tomosynthesis (DBT) Option on 3/3/17 (this applies to the 2D part of the unit only).
  • Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option on 1/10/17
  • Siemens Mammomat Fusion on 09/14/15
  • Siemens Mammomat Inspiration with Tomosynthesis Option (DBT) System on 4/21/15
  • GE SenoClaire Digital Breast Tomosynthesis (DBT) System on 8/26/14
  • Fuji Aspire Cristalle Full-Field Digital Mammography (FFDM) System on 03/25/14

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
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
iCRco 3600M Mammography CR System
 
01/20/15
02/03/15
 
 
 
Siemens Mammomat Fusion 
09/21/15
09/21/15
09/21/15
09/21/15
GE Senographe Pristina with Digital Breast Tomosynthesis (DBT) Option (this applies to the 2D part of the unit only)
03/03/17
03/03/17
03/03/17
03/03/17

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

Page Last Updated: 04/11/2017
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