Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart G — Miscellaneous Devices](/submissions/RA/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 892.6500](/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/892.6500) → IWT — Shield, Gonadal

# IWT · Shield, Gonadal

_Radiology · 21 CFR 892.6500 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/IWT

## Overview

- **Product Code:** IWT
- **Device Name:** Shield, Gonadal
- **Regulation:** [21 CFR 892.6500](/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/892.6500)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K930763](https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/IWT/K930763.md) | FIGLEAF SHIELD | Byers Industries, Inc. | May 17, 1993 | SESE |
| [K833523](https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/IWT/K833523.md) | C.B. RADIOLOGY DESIGN GONADSHIELD | Radiology Design | Nov 21, 1983 | SESE |

## Top Applicants

- Radiology Design — 1 clearance
- Byers Industries, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/IWT](https://fda.innolitics.com/submissions/RA/subpart-g%E2%80%94miscellaneous-devices/IWT)

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