← Product Code [IWE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE) · K950293

# TEC-2110 GREEN LASER MODEL MT-HNG (K950293)

_Medtec, Inc. · IWE · Aug 18, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE/K950293

## Device Facts

- **Applicant:** Medtec, Inc.
- **Product Code:** [IWE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE.md)
- **Decision Date:** Aug 18, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5780
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE/K950293](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE/K950293)

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