21 CFR 892.1400 — Source, Calibration, Sealed, Nuclear
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1400
Identification
A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IXD | Source, Calibration, Sealed, Nuclear | 1 | 2 |
