(i) Systems used to perform noninterventional problem solving procedures shall have radiographic magnification capability available for use by the operator.
(ii) Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.
- Must all mammographic units have magnification capabilities?
- A facility's x-ray unit has two magnification attachments that provide a magnification of 1.5 or 2.2, depending on which attachment is used. Other values specified in the regulation cannot be achieved using that unit. Must a facility purchase new attachments to cover the range, and does it mean that magnification at the 2.2 level must be discontinued?
- In 21 CFR 900.12(b)(6)(i) what does the phrase "available for use by the operator" mean?
- We are a screening facility that schedules only asymptomatic patients for mammography. Our equipment cannot perform magnification. Are we permitted to perform additional views on patients who unexpectedly report an abnormality or area of concern at the time of the study or who have an abnormality detected during the screening mammogram, or must we refer such patients to another facility that has magnification capabilities?