The new article addresses FDA guidelines related to models and assembly procedures for diagnostic X-ray equipment, emphasizing unique model identification, assembly responsibilities, and compliance with regulatory standards.
The new article provides guidance on accidental radiation occurrences (AROs), record-keeping responsibilities, and managing defects in diagnostic x-ray systems.
The new article focuses on fluoroscopic X-ray systems and the regulatory requirements established, particularly changes effective on June 10, 2006, providing guidance on compliance, system modifications, and operational features.