← Product Code [IXC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC) · K922079

# ROTOLUX, SELECTOLUX, SHUTTERVUE (K922079)

_American Medical Sales, Inc. · IXC · Jun 16, 1992 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC/K922079

## Device Facts

- **Applicant:** American Medical Sales, Inc.
- **Product Code:** [IXC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC.md)
- **Decision Date:** Jun 16, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1890
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC/K922079](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC/K922079)

**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