Radiation-Emitting Products

Are there any specific requirements for the mechanism of the display required by 900.12(b)(9)(iii)?

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No. Under a separate FDA performance standard, the Diagnostic X-ray Performance Standard, the display must be clear, legible, and visible to the operator at the unit or the operator control location. The actual mechanism can be achieved in any manner that provides the required information in an unambiguous fashion.

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Page Last Updated: 06/23/2014
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