IYQ · Phantom, Flood Source, Nuclear
Radiology · 21 CFR 892.1380 · Class 1
Overview
| Product Code | IYQ |
|---|---|
| Device Name | Phantom, Flood Source, Nuclear |
| Regulation | 21 CFR 892.1380 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
