← Product Code [IZW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW) · K843244

# LIGHT BEAM COLLIMATOR (K843244)

_Dealers X-Ray Co., Inc. · IZW · Sep 14, 1984 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K843244

## Device Facts

- **Applicant:** Dealers X-Ray Co., Inc.
- **Product Code:** [IZW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW.md)
- **Decision Date:** Sep 14, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1610
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K843244](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K843244)

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