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?

Policy Guidance Help System logo

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.

Back to Light Fields

Page Last Updated: 07/11/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.