← Product Code [IZF](/productcode/IZF) · K892653

# TOMAX ULTRASCAN (K892653)

_Incubation Industries, Inc. · IZF · Aug 28, 1989 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K892653

## Device Facts

- **Applicant:** Incubation Industries, Inc.
- **Product Code:** [IZF](/productcode/IZF.md)
- **Decision Date:** Aug 28, 1989
- **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/K892653](https://fda-staging.innolitics.com/device/K892653)

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