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3.1 Testing Summary
This section of the document applies to those procedures required to execute the Medical Physicist role in the QC of
the Xpress Digital Mammography System.
These tests should only be carried out by a qualified medical physicist in accordance with 21 CFR 900.12(a)(3)
which denes these qualications.
This section of the document provides the following information:
• Test requirements in compliance with MQSA 21 CFR 900.12(e)(5), 900.12(e)(6), and 900.12(e)(9).
• Test objectives.
• Recommended frequency to perform the test item.
• Required equipment in order to successfully perform each procedure.
• Procedures to ensure the equipment is operating properly.
• Analysis interpretation criteria and recommendations.
• Performance criteria and corrective action in compliance with minimum MQSA regulatory requirements.
• Documentation.
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