<html xmlns="http://www.w3.org/1999/xhtml"><head><meta charset="UTF-8" /><title></title><meta name="Generator" content="PowerTools for Open XML" /><style>span { white-space: pre-wrap; } p.sb35e16a8-a934-48cb-b412-3dc11365d270P0 { margin-top: 0; margin-bottom: 0; margin-left: 0; margin-right: 0; text-indent: 0.00in; text-align: justify; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; } span.sb35e16a8-a934-48cb-b412-3dc11365d270C0 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.sb35e16a8-a934-48cb-b412-3dc11365d270C0-000000 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.sb35e16a8-a934-48cb-b412-3dc11365d270C0-000001 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.sb35e16a8-a934-48cb-b412-3dc11365d270000002 { color: black; background: white; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.sb35e16a8-a934-48cb-b412-3dc11365d270C0-000003 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } </style></head><body><div><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    </span><a href="https://sdlegislature.gov/Rules?Rule=44:03:01:11.03"><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000000">44:03:01:11.03</span></a><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000001">.  Notification of installation of radiation equipment.</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0"> Any assembler who installs radiation machines in this state shall report to the department within </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">fifteen</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0"> days the following information:</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270000002"> </span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    (1)  The name and address of the persons who have received these machines;</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    (2)  The manufacturer, model, and serial number of each radiation machine and major components transferred;</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    (3)  The date of transfer of each radiation machine; and</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    (4)  The date of installation of each radiation machine.</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270000002"> </span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    In the case of diagnostic X ray systems which contain certified components, </span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">the licensee must submit </span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">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 </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">April</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0"> 1, </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">2022</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">, to the department within </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">fifteen</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0"> days following completion of the assembly.</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270000002"> </span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">For the purposes of this section, assembler means any person, including the owner of the X ray system or the owner s employee or agency, engaged in the business of assembling, replacing, or installing one or more components into an X ray system or subsystem that is subsequently used to provide professional or commercial services</span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">.</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270000002"> </span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000001">Source:</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0"> 26 SDR 96, effective January 23, 2000</span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">; 50 SDR 41, effective October 11, 2023</span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">.</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000001">General Authority:</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-15"><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000003">34-21-15</span></a><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">.</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">    </span><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000001">Law Implemented:</span><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-4.1"><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000003">34-21-4.1</span></a><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-21-17"><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0-000003">34-21-17</span></a><span class="sb35e16a8-a934-48cb-b412-3dc11365d270C0">.</span></p><p dir="ltr" class="sb35e16a8-a934-48cb-b412-3dc11365d270P0"><span xml:space="preserve" class="sb35e16a8-a934-48cb-b412-3dc11365d270000002"> </span></p></div></body></html>