Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1610](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1610) → IZT — Cone, Radiographic

# IZT · Cone, Radiographic

_Radiology · 21 CFR 892.1610 · Class 2_

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

## Overview

- **Product Code:** IZT
- **Device Name:** Cone, Radiographic
- **Regulation:** [21 CFR 892.1610](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1610)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

## Classification Rationale

Class II (special 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.

## Special Controls

*Classification.* Class II (special 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 |
| --- | --- | --- | --- | --- |
| [K924759](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZT/K924759.md) | COLLIMATOR LIGHT SOURCE | Denar Corp. | Dec 9, 1992 | SESE |

## Top Applicants

- Denar Corp. — 1 clearance

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

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