Assembler and/or Transfer Obligation

(A) Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines in this Commonwealth shall notify the Agency within 15 days of: (1) The name and address of persons who have received these machines; (2) The manufacturer, model, and serial number of each radiation machine transferred; and, (3) The date of transfer of each radiation machine. (4) In the case of diagnostic x-ray system 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 Agency within 15 days following completion of the assembly. Such report shall suffice in lieu of any other by the assembler. (B) No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and use shall meet the requirements of 105 CMR 120.000.