X Ray Apparatus & Tubes Forms for Hennepin
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FAQ
Federal regulations (Section 21 CFR 1020.30(d)) require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly (Form FDA 2579) to FDA within 15 days following the completion of the assembly.
The engineer should send the original and three carbon copies to the following locations: White Original Mail to the FDA. Yellow copy Mail to State Radiology Health Department. Pink copy Left onsite for you, the equipment owner.
The report of assembly (Form 2579) represents the assemblers certification that the system or component(s) are of the type called for by the Standard (i.e., certified), have been assembled according to the instructions provided by the manufacturer, and meets the requirements of the applicable Federal standards
rays are commonly produced in ray tubes by accelerating electrons through a potential difference (a voltage drop) and directing them onto a target material (i.e. tungsten). The incoming electrons release rays as they slowdown in the target (braking radiation or bremsstrahlung).
Federal regulations (Section 21 CFR 1020.30(d)) require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly (Form FDA 2579) to FDA within 15 days following the completion of the assembly.