Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1420](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1420) → JAR — Phantom, Test-Pattern, Radionuclide

# JAR · Phantom, Test-Pattern, Radionuclide

_Radiology · 21 CFR 892.1420 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAR

## Overview

- **Product Code:** JAR
- **Device Name:** Phantom, Test-Pattern, Radionuclide
- **Regulation:** [21 CFR 892.1420](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1420)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAR](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAR)

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