Radiation-Emitting Products

Digital Accreditation

Note to MAMMOGRAPHY FACILITY STAFF: If you have questions about the MQSA Program, please call the MQSA Facility Hotline at 1-800-838-7715 or email your questions to MQSAhotline@versatechinc.com


Facilities with Full Field Digital Mammography-only (FFDM-only) units do not need to apply to the FDA for an extension of their MQSA certification to include the use of an FFDM-only unit. All Accreditation Bodies (ABs) are approved by FDA to accredit all FFDM-only units and all FFDM-only units must be accredited by one of these ABs.

Facilities with Digital Breast Tomosynthesis (DBT) units must apply to their AB for the accreditation of the FFDM portion of the DBT unit, and then apply to and be approved by the FDA for an extension of their certification to include the use of the DBT portion of the unit, prior to using the unit to image patients. The exception are such facilities located in the State of Arkansas. Please see the section below entitled "FDA-Approved Accreditation Bodies (ABs) for DBT Units."

Requests for MQSA certification extension to include a DBT unit need to include all the information listed in the document MQSA Facility Certification Extension Requirements and should be submitted electronically at DBTelectronicsubmission@fda.hhs.gov or hardcopies forwarded to:

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 for Facilities Utilizing a DBT System with FFDM Images (either directly acquired or synthesized)

Currently, some FDA-approved ABs are not prepared to accredit DBT. FDA developed the certification extension program to cover situations where a mammography device has been approved for marketing but where an AB has not yet been approved to accredit DBT. The certification extension program that is currently in effect provides that facilities whose ABs cannot currently accredit DBT can legally use that portion of the unit if an FDA-approved accreditation body first accredits the FFDM component of the DBT unit.

Please contact your accreditation body for information on the types of images it accepts for accreditation as well as on how to submit images.

Unless your accreditation body is approved to accredit your DBT unit, you must first accredit the FFDM portion of your DBT unit with your accreditation body, and then apply to the FDA for certification extension for the DBT component by visiting the DBT Certification Extension Requirements page.

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

DBT Systems

Below is a list of DBT units approved by FDA for marketing for use in mammography facilities, with their respective dates of market approval:

  • GE Senographe Pristina with Digital Breast Tomosynthesis (DBT) Option — 03/3/2017
  • Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option — 01/10/2017
  • Siemens MAMMOMAT Inspiration with Digital Breast Tomosynthesis (DBT) Option — 04/21/2015
  • GE SenoClaire Digital Breast Tomosynthesis (DBT) System — 08/26/2014
  • Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System — 02/11/2011

Facilities with FFDM-only units must apply for accreditation from one of the FDA-approved ABs. It is no longer necessary to apply to FDA for certification extension to cover any FFDM-only unit.

FDA-Approved Accreditation Bodies (ABs) for DBT Units

Only one AB, the State of Arkansas (SAR), is currently FDA-approved to accredit both the FFDM and DBT portions of certain DBT units. If your facility is located in Arkansas, you must apply to the SAR AB for accreditation of the DBT units indicated in the table below. If you are an Arkansas facility and you have recently sent the FDA an application for the certification extension program, your facility's information will be transferred to the SAR AB and we will notify you that that has been done. Such facilities should no longer send applications for certification extension to the FDA. (Note: If your facility is located in Arkansas but the FFDM portion of your DBT unit is accredited by the ACR, please contact the SAR AB to discuss transferring that accreditation to SAR. Contact information for the SAR AB can be found on our Accreditation Bodies page.)

Digital Breast Tomosynthesis (DBT) Units Effective Date for DBT accreditation approval
ACR SAR SIA STX
Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System (Both FFDM and DBT) * 06/01/17 * *
GE SenoClaire Digital Breast Tomosynthesis (DBT) System * * * *
Siemens MAMMOMAT Inspiration with Digital Breast Tomosynthesis (DBT) Option (Both FFDM and DBT) * 06/08/17 * *
Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option (Both FFDM and DBT) * 06/08/17 * *
GE Senographe Pristina with Digital Breast Tomosynthesis (DBT) Option * * * *

* Prior to using the unit to image patients, a facility must apply to and be approved by the FDA for an extension of their certification to include the use of the DBT portion of the unit.

We will update this chart as additional ABs are approved to accredit DBT. 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: 06/14/2017
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