← Product Code [IZF](/productcode/IZF) · K780319

# ORBITOME-UG (K780319)

_Philips Medical Systems (Cleveland), Inc. · IZF · Mar 14, 1978 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K780319

## Device Facts

- **Applicant:** Philips Medical Systems (Cleveland), Inc.
- **Product Code:** [IZF](/productcode/IZF.md)
- **Decision Date:** Mar 14, 1978
- **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.

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**Source:** [https://fda-staging.innolitics.com/device/K780319](https://fda-staging.innolitics.com/device/K780319)

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