Performance specifications
We perform the physical laboratory test according to the 'Display Devices for Diagnostic Radiology – Guidance
for Industry and Food and Drug Administration Staff' like below and we set the acceptance criteria for the
physical laboratory test, the product was all passed according to the criteria.
Test detail
1
Spatial resolution
- Measurements of the transfer of information from the image data to the luminance fields at different
spatial frequencies of interest typically done by reporting the modulation transfer function.
2
Pixel defects
- Measurements (count, types (e.g., sub-pixel or entire pixel), always-on, always-off), and locations (map)
of pixel defects.
3
Artifacts
- Evaluate for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern for
a period of time.
4
Temporal response
- Measurements of the temporal behavior of the display in responding to changes in image values from
frame to frame.
5
Luminance (achievable and recommended)
- Measurements of the luminance that the device outputs as used in the application under recommended
conditions and the achievable values if the device is set to expand the range to the limit.
6
Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF)
- Measurements of the mapping between image values and the luminance output following a target model
response for 256 or more levels.
7
Color tracking
- Chromaticity at different luminance levels of gray shades, including the white point, as indicated by the
color coordinates in an appropriate units system
46
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