21 CFR 892.1370 — Phantom, Anthropomorphic, Nuclear
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1370
Identification
A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments.
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 |
|---|---|---|---|---|
| IYP | Phantom, Anthropomorphic, Nuclear | 1 | 3 |
