SECTION 310:281-3-6. Assembler and/or transferor obligation  


Latest version.
  • (a)   Except as provided under 310:281-3-2(b), any person who sells, leases, transfers, lends, disposes, assembles, or installs diagnostic x-ray systems in this state shall record the following information and submit it to the Department within 15 days:
    (l)   the name and address of persons who have received these systems;
    (2)   the manufacturer, model, and serial number of each diagnostic x-ray system transferred; and
    (3)   the date of transfer of each diagnostic x-ray system.
    (b)   In the case of diagnostic x-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the Federal diagnostic x-ray standard (21 CFR 1020.30 (d)) shall be submitted to the Department within 15 days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.
    (c)   No person shall make, sell, lease, transfer, lend, assemble, or install diagnostic x-ray systems or the supplies used in connection with such systems unless such supplies and systems when properly placed in operation shall meet the requirements of these regulations.
[Source: Added at 8 Ok Reg 3503, eff 8-15-91 (emergency); Added at 9 Ok Reg 1643, eff 5-29-92; Amended at 21 Ok Reg 1037, eff 5-13-04]