← Product Code [KPW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW) · K820306

# RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (K820306)

_Tecnomed, Inc. · KPW · Mar 5, 1982 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K820306

## Device Facts

- **Applicant:** Tecnomed, Inc.
- **Product Code:** [KPW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW.md)
- **Decision Date:** Mar 5, 1982
- **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/KPW/K820306](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPW/K820306)

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