Section 180-2-011 - ASSEMBLER OR TRANSFER OBLIGATIONA person who sells, leases, transfers, lends, disposes, assembles, or installs radiation generating equipment or components which affect radiation output in this State must notify the Department within 15 days of:
(A) The full name and address of persons who have received this equipment;(B) The manufacturer, model, and serial number of each radiation generating equipment transferred; and(C) The date of transfer of radiation generating equipment. 011.01ASSEMBLER'S REPORT. In the case of diagnostic x-ray systems which contain certified components, the registrant may submit a copy of the assembler's report (Form FDA 2579) prepared in compliance with requirements of 21 CFR § 1020.30(d), in place of any other report by the assembler.011.02REQUIREMENTS OF ASSEMBLER'S. No person may make, sell, lease, transfer, lend, assemble, or install radiation generating equipment or the components used in connection with radiation generating equipment unless those components and equipment, when properly placed in operation, meet the requirements of Title 180.180 Neb. Admin. Code, ch. 2, § 011
Amended effective 10/20/2020