Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1960](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1960) → QHX — Fluoroscopic X-Ray Image Intensifier

# QHX · Fluoroscopic X-Ray Image Intensifier

_Radiology · 21 CFR 892.1960 · Class 1_

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

## Overview

- **Product Code:** QHX
- **Device Name:** Fluoroscopic X-Ray Image Intensifier
- **Regulation:** [21 CFR 892.1960](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1960)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

## 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 § 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/QHX](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHX)

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