Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1380](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1380) → IYQ — Phantom, Flood Source, Nuclear

# IYQ · Phantom, Flood Source, Nuclear

_Radiology · 21 CFR 892.1380 · Class 1_

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

## Overview

- **Product Code:** IYQ
- **Device Name:** Phantom, Flood Source, Nuclear
- **Regulation:** [21 CFR 892.1380](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1380)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## 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._

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com