Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1730](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1730) → OIL — Discography Kit

# OIL · Discography Kit

_Radiology · 21 CFR 892.1730 · Class 2_

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

## Overview

- **Product Code:** OIL
- **Device Name:** Discography Kit
- **Regulation:** [21 CFR 892.1730](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1730)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. 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 discography kit intended for use with a photofluorographic 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 discography kit intended for use with a photofluorographic 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/OIL](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OIL)

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