The American College of Radiology (ACR) has received authorization from the U.S. Food and Drug Administration (FDA) to manage the accreditation process for FDA-approved digital breast tomosynthesis (DBT) units, effective April 9.
Starting April 6, all applicants seeking to get accreditation for the following DBT technologies will need to contact the ACR:
- Fujifilm Medical Systems USA's Aspire Cristalle
- GE Healthcare's Senographe Pristina
- GE's SenoClaire
- Hologic's Selenia Dimensions
- Siemens Healthineers' Mammomat Inspiration
The society plans to contact facilities that already own DBT devices under an FDA-approved extended Mammography Quality Standards Act (MQSA) certificate to discuss next steps for accreditation.
