← Product Code [MQB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB) · K031198

# SCANX 10 (K031198)

_Air Techniques, Inc. · MQB · Jun 20, 2003 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K031198

## Device Facts

- **Applicant:** Air Techniques, Inc.
- **Product Code:** [MQB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB.md)
- **Decision Date:** Jun 20, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1680
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K031198](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K031198)

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