Current through September 30, 2024
Section 892.1380 - Nuclear flood source phantom(a)Identification. A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response.(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