Radiation-Emitting Products

With machines such as the GE 500T and 600T, which do not have a separate mechanism for compression fine adjustment, can tapping the foot pedal for fine adjustment of compression force meet the year 2002 requirement?

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Yes. After receiving input from the National Mammography Quality Assurance Advisory Committee, comments from the public, and performing its own evaluation, FDA has determined that, with proper use, fine compression can be achieved with GE 500T and 600T units by tapping the foot pedal. While FDA recognizes that fine compression can be achieved using these mammography units, the specifics of the compression device require the technologist to pay additional attention during the application of compression. Where this causes clinical problems, facilities may want to consider modifying the compression device to allow for more consistent operator control. Facilities wishing to modify their units may try contacting third-party vendors offering such modifications for more information. Before a facility decides to modify the compression device, the facility should assure itself that the unit meets all the other equipment requirements.

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Page Last Updated: 08/13/2014
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