Radiation-Emitting Products

We have a DMR unit in which the automatic decompression override status is displayed only under certain conditions, does this still meet the requirement to be continuously displayed?

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Yes. If the "certain conditions" referred to are:

  1. If the automatic decompression override status displays only when compression is applied, or
  2. If there are other messages displayed in addition to the override status, so that the display of the override status will cycle with the other messages, thus override status will be interrupted briefly while the other messages are displayed (this feature is also characteristic of some other models of GE mammographic units).

FDA determined that these conditions satisfy the intent of the requirement, which is that there must be means to alert the operator to the status of the automatic decompression override so that he or she may change that status, if he or she wishes, before producing the mammographic images.

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Page Last Updated: 08/11/2014
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