← Product Code [IWE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE) · K800223

# PATIENT POSITIONING SYSTEM 1D OR 2D (K800223)

_Laboratoire National D'Essais · IWE · Mar 3, 1980 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE/K800223

## Device Facts

- **Applicant:** Laboratoire National D'Essais
- **Product Code:** [IWE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE.md)
- **Decision Date:** Mar 3, 1980
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE/K800223](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWE/K800223)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
