Radiation-Emitting Products

Light Fields

Policy Guidance Help System logo


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.


  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?


Page Last Updated: 07/25/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English