Radiation-Emitting Products

MQSA Alternative Standard #4: Post exposure indication of the machine pre-selected focal spot and or target material

This alternative standard was approved on April 19, 1999 and became effective on April 28, 1999 for Senographe™ DMR GE machines. It has no time limit. 

The final regulation and its alternative standard are stated below:

21 CFR 900.12(b)(7) states that:

(7) Focal spot selection.

(i)  When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected

(ii)  When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material. 

(iii)  When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.

The approved alternative is:

(7)  Focal spot selection.

(i)  When more than one focal spot and/or more than one target material is provided, the system shall indicate, prior to exposure, the pre-selected focal spot and target material, and shall indicate, after the exposure, the focal spot and test material actually used during the exposure; or

(ii) When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall indicate, after the exposure, the target material and/or focal spot actually used during the exposure.

Under the approved alternative, an indication of the pre-exposure focal spot and target material would no longer be required when the pre-exposure target material and focal spot are set by a system algorithm based on exposure and the user has no control over that selection. In operating modes where the user has control of the pre-selected focal spot and/or target material, indication of the pre-selected values would still be required. In all cases, indication of the focal spot and/or target material actually used during the exposure would be required.

 

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Page Last Updated: 09/25/2014
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