21 CFR 892.1420 — Phantom, Test-Pattern, Radionuclide
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1420
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JAR | Phantom, Test-Pattern, Radionuclide | 1 | 0 |
