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Thursday, July 22, 2010 12:37:17 PM
See this link. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107549.htm#ft11
From this link I cut and paste here
"We recommend that you provide a complete description of the FFDM system display accessory as discussed below.
Soft-Copy Display System
Soft-copy display systems include a display device or monitor and a display controller. We recommend you provide the following:
a complete description of the entire display system, including the display device, display controller or graphics card, and software for the control of display functions, calibration, and image manipulation;
the speed and bit-depth precision of digital-to-analog converters;
the physical size of the display available for image visualization; and
the pixel array dimensions, pixel size, and pixel pitch."
Dean should have recommended/submitted the entire Computer CPU box where he plays with the images. This is my suggestion for practicality. This is a no-miss solution.
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