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14. QUALITY ASSURANCE
This section will occasionally use procedures described in previous sections.
Please refer to those sections when needed.
In order to assure image quality of the equipment, Quality Assurance (QA)
Phantoms will be provided (Reference 21CFR 1020.33 (d)(1)) to test of the
system performance and quality. These phantoms were designed to provide
maximum performance information with minimum effort.
During the installation or after a repair this QA procedure will create a
baseline performance data.
Make a periodic evaluation and compare with the baseline data.
If degradation in image quality or a change in QA values is noticed, contact
the Alliage Service Department.
For 2D images it will be validating the beam position, geometric calibration
and the maximum contrast resolution. The QA phantoms are show below.
QA Phantom for Panoramic*
Resolution Test Phantom*
*Not included. Order on request
For 3D images, it will be validating six aspects of image quality
Contrast Scale
High Contrast Spatial Resolution
Low Contrast Detectability
Noise and Uniformity
Slice Thickness
Measuring Reference Material
The QA phantoms are show below.
Summary of Contents for EAGLE 3D
Page 1: ......
Page 91: ...90 16 5 1 TUBE CHARACTERIZATION...
Page 93: ...92...
Page 94: ...93...
Page 96: ...95 16 6 3 ANALOG CEPH LATERAL EXAM 16 6 4 ANALOG CEPH FRONTAL EXAM 16 6 5 TOMOGRAPHIC EXAM...
Page 97: ...96...