This document defines the minimum set of Quality Control (QC) tests to be applied to the [Manufacturer to enter commercial name], a [Manufacturer to specify display or workstation] labeled for final interpretation of images acquired using a full-field digital mammography (FFDM) image acquisition system. This document is intended to constitute an element of the Quality Assurance Plan (QAP) of the mammographic facility.

Except for the Phantom Image Quality Test, Sec. 3.5, these tests are intended to monitor the performance of the [Manufacturer to specify display or workstation] as a component of the full-field digital mammography system and not the performance of the system as a whole. Hence, a characteristic such as compatibility of the component with the communication protocols used in an imaging network is not an element of these tests.

These tests are intended to monitor the consistency over time of the device’s performance. While they may be included as elements of acceptance testing, they are not intended to represent the entirety of an acceptance test.

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