← Product Code [IZF](/productcode/IZF) · K811302

# SOMATOM 2N (K811302)

_Siemens Corp. · IZF · Jun 23, 1981 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K811302

## Device Facts

- **Applicant:** Siemens Corp.
- **Product Code:** [IZF](/productcode/IZF.md)
- **Decision Date:** Jun 23, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1740
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

---

**Source:** [https://fda-staging.innolitics.com/device/K811302](https://fda-staging.innolitics.com/device/K811302)

**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
