900.12(e)(5)(vi): Dosimetry. The average glandular dose delivered during a single craniocaudal view of an FDA-accepted phantom simulating a standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure. The dose shall be determined with technique factors and conditions used clinically for a standard breast.
- My facility uses two distinct groups of small size cassettes of different speed classes to image the standard breast. Must annual dose measurements be obtained for both groups of cassettes?
- We are using an FDA cleared single-use cushion pad when performing mammograms on some of our patients. Do we have to include the pad when performing the phantom and dose QC tests?