Radionuclide test pattern phantom.

(a) Identification. A radionuclide test pattern phantom is a device that consists of an arrangement of radiopaque or radioactive material sealed in a solid pattern intended to serve as a test for a performance characteristic of a nuclear medicine imaging device. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. [53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001]