21 CFR 892.1380 — Phantom, Flood Source, Nuclear
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1380
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.
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 |
|---|---|---|---|---|
| IYQ | Phantom, Flood Source, Nuclear | 1 | 0 |
