1. (1) Within fifteen calendar days, any agent who sells, leases, transfers, lends, disposes of, assembles, repairs, replaces, or installs radiation machines or components in Washington state shall notify the department of the:

   1. (a) Recipient's name and radiation machine facility address;
   2. (b) Manufacturer, model, and serial number of each radiation machine master control; and
   3. (c) Date of transfer of the radiation machine.
2. (2) An agent may use the FDA form 2579 or equivalent to meet the notification requirements of subsection (1) of this section.

3. (3) An agent who installs X-ray systems, controls, or components shall ensure that the radiation machines, accessories, or components, including exposure switch placement, meet the applicable requirements of:

   1. (a) Chapter 246-225 WAC;
   2. (b) Chapter 246-225A WAC;
   3. (c) Chapter 246-226 WAC;
   4. (d) Chapter 246-227 WAC;
   5. (e) Chapter 246-228 WAC; and
   6. (f) Chapter 246-229 WAC.

4. (4) An agent shall not install or transfer a radiation machine if the registrant does not submit:

   1. (a) A required plan review according to chapter 246-225, 246-226, or 246-227 WAC; or
   2. (b) Shielding plan or radiation machine facility design, or both if required.
5. (5) An agent shall assemble certified X-ray systems according to 21 C.F.R., Sec. 1000 through 1050 (2018) so that manufacturer's specifications and intended performance designs are met.

[Statutory Authority: RCW 43.20B.020, 43.70.110, 43.70.250, and 70.98.080. WSR 19-05-074, § 246-224-0100, filed 2/19/19, effective 3/22/19. Statutory Authority: RCW 70.98.050 and [70.98.]080. WSR 02-14-050, § 246-224-0100, filed 6/27/02, effective 7/28/02.]