E Berns1*, (1) University of Colorado Health Science, Denver, COSU-D-Salon CD-1 Sunday 4:00:00 PM - 5:00:00 PM Room: Salon CD
Eric Berns, PhD, DABR
Digital mammography has become the technology of choice for breast imaging with many FDA-approved systems already available and more on the way. Currently the FDA requires facilities to use quality control manuals published by the FFDM unit manufacturer. There are several accrediting bodies that run programs approved by the FDA. This lecture will provide updates on the FDA activities, ACR requirements, the upcoming ACR DM QC Manual for digital mammography. Approval and accreditation processes for Digital Breast Tomosynthesis will also be introduced.
1. Understand the requirements for accrediting FFDM systems
2. Understand the requirements for certifying tomosynthesis systems with the FDA
3. Be able to navigate the ACR and FDA websites to find required information and documents for certification and accreditation.
Advances in Full Field Digital Mammography
Mark Seddon, MS DABR
In 2011 the FDA switched form a Pre-Market Approval (PMA) process to approve Full Field Digital Mammography (FFDM) systems to their 510k approval process. Since that time 19 new systems or variations of existing systems have been approved full field digital mammography. These systems include computed radiography systems, full field detector systems with new and existing detector technologies and a photon counting system. At the time of the switch there were five vendors with approved systems, there are now thirteen vendors in the FFDM market. Tomosynthesis and 2D synthesized images for interpretation have also been approved for screening mammography.
This lecture will give the medical physicist information on the systems approved since 2011. Included will be information on detector technology, some of the differences in QC for the different vendors, and some of the new technologies that are being used to lower dose for patient imaging.
1. Understand the new detector technologies since 510k.
2. Be able to find information needed to perform acceptance testing and continuing QC on the new systems.
3. Understand some of the new technologies being employed to lower patient dose in FFDM.
- 87-22801-326454-102507.pdf (E Berns)