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U.S. Department of Health and Human Services

Radiation-Emitting Products

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We have a screen-film unit that we are converting to FFDM-computed radiography (CR) use. We know that we have to perform a Mammography Equipment Evaluation (MEE) on the CR system prior to clinical use. However, since the unit underwent an MEE when it was first installed and has had subsequent testing as part of the annual physics survey does it have to undergo a new MEE or can we use its orig...

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For those tests that are unit specific and independent of the computed radiography (CR) system, FDA interprets 21 CFR 900.12(e)(10) to mean that you may use the test results from previous annual physics surveys or MEEs as long as the tests were performed within the last six months. For those MEE tests that evaluate the performance of the whole imaging chain and help to ensure that all the system components are compatible, such as the phantom image, and other tests that may be listed in the CR manufacturer’s QC manual, FDA interprets 21 CFR 900.12(e)(10) to mean that you cannot use prior tests. The medical physicist must perform these MEE tests on the accessory components prior to using the components in patient examinations.

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