JAR · Phantom, Test-Pattern, Radionuclide
Radiology · 21 CFR 892.1420 · Class 1
Overview
| Product Code | JAR |
|---|---|
| Device Name | Phantom, Test-Pattern, Radionuclide |
| Regulation | 21 CFR 892.1420 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A radionuclide test pattern phantom is a device that consists of an arrangement of radiopaque or radioactive material sealed in a solid pattern intended to serve as a test for a performance characteristic of a nuclear medicine imaging device.
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.
