44:03:01:11.03. Notification of installation of radiation equipment. Any assembler who installs radiation machines in this state shall report to the department within 15 days the following information:
(1) The name and address of the persons who have received these machines;
(2) The manufacturer, model, and serial number of each radiation machine and major components transferred;
(3) The date of transfer of each radiation machine; and
(4) The date of installation of each radiation machine.
In the case of diagnostic X ray systems which contain certified components, a copy of the assembler's report, Form FDA 2579 (6/95), prepared in compliance with requirements of the Federal Diagnostic X Ray Standard, 21 C.F.R. 1030.30(d), as of January 1, 1998, shall be submitted to the department within 15 days following completion of the assembly.
Source: 26 SDR 96, effective January 23, 2000.
General Authority: SDCL 34-21-15.
Law Implemented: SDCL 34-21-4.1, 34-21-17.
Back to 44:03:01