(DBT) System

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Digital Breast Tomosynthesis FDA approved the first DBT system in late 2010 Currently FDA allows use of DBT under MQSA through certificate extension process DBT can be installed only in already MQSA certified mammography facilities 2
Certificate Extension I What is Certificate Extension? FDA’s Division of Mammography provide the Certificate Extension for a newly cleared /approved mammography system or a modality where no accreditation body is available Why does FDA give Certificate Extension ? FDA provides certificate extension to facilitate the use of a device which received marketing clearance or approval. 3
Page 1: Facility Certification Extension Re
Page 5 and 6: MQSA statute requires that a facili
Page 7 and 8: What does FDA review for Certificat
Page 9 and 10: AEC Function Performance Corrected
Page 11 and 12: Mammography vs. Tomosynthesis: Reso
Page 13 and 14: “The doses for 2D and tomosynthes
Page 15 and 16: Questions and Answers Can a facilit
Page 17: Questions and Answers 3. What are t

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