Diagnostic X-ray Systems and Their Major Components; Amendments to Performance Standard--FDA. Final Rule

The Food and Drug Administration (FDA) is amending the performance standard for diagnostic x-ray systems and their major components by revising and adding requirements concerning computed tomography x-ray (CT) systems. CT systems are new medical diagnostic tools whose use in the United States has grown significantly in recent years. Because CT systems have many performance features that are unlike conventional x-ray systems, the current performance standard for diagnostic x-ray systems is not entirely appropriate for CT systems. The amendments to the standard address the special characteristics of CT systems.