Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1840](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1840) → LQA — Media, Reusable Image

# LQA · Media, Reusable Image

_Radiology · 21 CFR 892.1840 · Class 1_

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

## Overview

- **Product Code:** LQA
- **Device Name:** Media, Reusable Image
- **Regulation:** [21 CFR 892.1840](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1840)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K854407](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LQA/K854407.md) | DIGIRAD REUSABLE IMAGE MEDIA | Digirad Corp. | Mar 10, 1986 | SESE |

## Top Applicants

- Digirad Corp. — 1 clearance

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

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