(DBT) System

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Mammography vs. Tomosynthesis: Images Projection image: Reconstructed image: Objects have a shadow in reconstructed tomosynthesis images! 14
Questions and Answers Can a facility perform patient imaging with DBT prior to FDA’s certificate extension approval? a. yes b. no c. yes, if application training is performed d. yes, if a written guarantee of the quality is provided to the patient e. yes, if a verbal OK is obtained from CDRH Answer: b Ref: MQSA Facility Certification Extension Requirements for Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System http://www.fda.gov/Radiation- EmittingProducts/MammographyQualityStandardsActandProgram/ FacilityCertificationandInspection/ucm243765.htm 15
Page 1 and 2: Facility Certification Extension Re
Page 3 and 4: Certificate Extension I What is Cer
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: “The doses for 2D and tomosynthes
Page 17: Questions and Answers 3. What are t

(DBT) System

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