Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680) → OIP — Radiology-Diagnostic Kit

# OIP · Radiology-Diagnostic Kit

_Radiology · 21 CFR 892.1680 · Class 2_

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

## Overview

- **Product Code:** OIP
- **Device Name:** Radiology-Diagnostic Kit
- **Regulation:** [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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