Radiation-Emitting Products

Does FDA have illumination requirements applicable to the collimator light on mammography x-ray systems? If so, do they apply to all systems?

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If the system is equipped with a light source to show the approximate size of the x-ray field or for positioning of the breast and this light passes through the x-ray beam-limiting device (collimator), then your system must have a minimum light output of 160 lux. The regulation only specifies this requirement if such a collimator-light field combination is provided.

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Page Last Updated: 07/11/2014
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