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Digital Breast Tomosynthesis: Basic Principles and the QMP's Role


J Dobbins

K Chakrabarti

J Dobbins1*, K Chakrabarti2*, (1) Duke University Medical Center, Durham, NC, (2) CDRH/FDA, Silver Spring, MD

WE-E-217BCD-1 Wednesday 2:00:00 PM - 3:50:00 PM Room: 217BCD

Digital breast tomosynthesis is a form of limited angle tomography, in which section (slice) images are produced from a series of discrete projection images acquired at different angles. Tomosynthesis can be useful in breast imaging by providing potentially better visibility of lesions over conventional mammography, especially in patients with dense breasts. This talk will cover the various physics aspects of DBT, including reconstruction algorithms, the importance of deblurring, and optimizing image acquisition parameters. Remaining important research questions in DBT will be presented and discussed. The presentation will also discuss MQSA Certificate extension process for currently approved digital breast tomosynthesis (DBT) systems. Training requirements, manufacturer required tests for Mammography Equipment Evaluation (MEE) as acceptance tests, and phantom imaging for the purpose of approval of certificate extension will be described. The talk will emphasize the specific tests where special attention must be given and will discuss how the techs should be advised to perform these tests.

Learning objectives:
1. To understand the fundamentals of tomosynthesis reconstructionâ¬, including deblurring, algorithm choice, and optimization
2. To understand FDAâ™s certificate extension process for DBTâ¬
3. To understand the requirements for MEE
4. To understand the required AEC tracking dataâ¬

Research sponsored in part by NIH, Siemens, and GE Healthcare.



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