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U.S. Department of Health and Human Services

About FDA

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Support of FDA Regulated X-Ray Products

This project provides the following services in support of FDA regulated x-ray products:

  • Performs accredited calibrations of detectors that measure radiation as a function of energy response to various NIST x-ray standard beams (specific kilo-voltage and filtration combinations). These calibrated detectors facilitate accurate radiation measurements of various beams encountered in medical x-ray.
  • Performs calibrations of kVp meter detectors that measure the kilo-voltage of medical x-ray machines.
  • Performs calibrations of photometers that are designed to measure the light falling on a specific area. These detectors measure the intensity of light that is used to define the radiation field of medical x-ray machines.
  • Performs operational checks to verify that Geiger–Müller (GM) detectors are responding to radiation within acceptable limits. The operation check is not a calibration. These meters are designed with amplified sensitivity, and are used for detecting rather than measuring radiation.
  • Provides equipment that is used for comparing the x-ray beam to light field alignment

 

Calibrations for 2010:

  • 90 radiation calibrations of general diagnostic instruments
  • 13 radiation calibrations of mammographic instruments
  • 26 electrical calibrations of radiation monitors
  • 9 calibrations of kilo-voltage meters
  • 5 calibrations of Photometers

 

The above 2010 calibrations were in support of x-ray inspections, interlaboratory comparisons, collaborative research projects, laboratory quality control, and instrument evaluations.