X Ray Apparatus & Tubes Forms for Tarrant
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FAQ
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
In order to perform radiologic procedures in Texas, Non-Certified Radiologic Technicians (NCTs) are required to be listed on the NCT Registry and work under the supervision of a licensed Texas physician, chiropractor, or podiatrist.
The machine sends a beam of radiation through your body. Your hard, dense bones block that beam, so they show up as white on the film below you. The radiation also goes through softer tissue like muscle and fat, which appear in shades of gray in the X-ray. The air in your lungs will look black in the image.
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.
In Texas, passing the exam offered by the American Registry of Radiologic Technologists (ARRT) or the Nuclear Medicine Technology Certification Board (NMTCB) is necessary to seek state licensure. Once licensure is initially obtained, 24 hours of continuing education is necessary every two years to seek renewal.
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.