Radiation-Emitting Products

Prohibited Equipment

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Citation:

900.12(b)(1): Regulations published under §1020.30, 1020.31, and 900.12(e) of this chapter that are relevant to equipment performance should also be consulted for a more complete understanding of the equipment performance requirements. (1) Prohibited equipment. Radiographic equipment designed for general purpose or special nonmammography procedures shall not be used for mammography. This prohibition includes systems that have been modified or equipped with special attachments for mammography. This requirement supersedes the implied acceptance of such systems in 1020.31(f)(3) of this chapter.

Questions:

  1. Must mammography units that are used exclusively for special interventional purposes (localization, biopsy or specimen radiography) be accredited? Must a facility that performs mammography only for such special purposes be accredited and certified?
  2. If an x-ray unit is sold for several uses including mammography and nonmammography applications, may it be used for mammography?
  3. We have a mammography unit that is used solely for interventional mammographic procedures. The unit is not MQSA certified. During the course of these interventional procedures, we take mammographic images. Because our unit is not MQSA certified, what restrictions exist on the mammographic images we may perform during such procedures?

 

Page Last Updated: 08/08/2014
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