21 CFR § 892.1400 Radiology Devices

§ 892.1400 Nuclear sealed calibration source.

Current through Sep 8, 2026 · Read all of Part 892

⚠ 3 pending changes to Part 892

(a) Identification. A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.

(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]

← § 892.1390 Radionuclide rebreathing system.§ 892.1410 Nuclear electrocardiograph synchronizer. →