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) → IZS — Aperture, Radiographic

# IZS · Aperture, Radiographic

_Radiology · 21 CFR 892.1610 · Class 2_

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

## Overview

- **Product Code:** IZS
- **Device Name:** Aperture, 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 |
| --- | --- | --- | --- | --- |
| [K895084](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZS/K895084.md) | APERTURE | Custom Medical Products, Ltd. | Oct 27, 1989 | SESE |

## Top Applicants

- Custom Medical Products, Ltd. — 1 clearance

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

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