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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Light Fields

Policy Guidance Help System logo

Citation:

900.12(b)(5): For any mammography system with a light beam that passes through the X-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.

Questions:  

  1. Does FDA have illumination requirements applicable to the collimator light on mammography x-ray systems? If so, do they apply to all systems?
  2. Who is responsible for performing the light beam test? How often should it be tested and by what method?
  3. Is there any specified minimum or maximum SID?