← Product Code [IZF](/productcode/IZF) · K810274

# CLINIX-R TOMOGRAPHIC DEVICE (K810274)

_Philips Medical Systems (Cleveland), Inc. · IZF · Mar 11, 1981 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K810274

## Device Facts

- **Applicant:** Philips Medical Systems (Cleveland), Inc.
- **Product Code:** [IZF](/productcode/IZF.md)
- **Decision Date:** Mar 11, 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/K810274](https://fda-staging.innolitics.com/device/K810274)

**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