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MEMORANDUM

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) March 1989

Download the Final Memorandum
Final
Docket Number:
FDA-2018-D-4115
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This letter states the Food and Drug Administration's (FDA) position regarding certain questions which arose after performance standards for CT systems were published. This letter supersedes the March 25, 1985, letter on the same subject.

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All written comments should be identified with this document's docket number: FDA-2018-D-4115.

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