← Product Code [IZL](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL) · K894643

# RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (K894643)

_Lorad Medical Systems, Inc. · IZL · Dec 14, 1989 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K894643

## Device Facts

- **Applicant:** Lorad Medical Systems, Inc.
- **Product Code:** [IZL](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL.md)
- **Decision Date:** Dec 14, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1720
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K894643](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZL/K894643)

**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