Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1000](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1000) → OIM — Mri Disposable Kit

# OIM · Mri Disposable Kit

_Radiology · 21 CFR 892.1000 · Class 2_

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

## Overview

- **Product Code:** OIM
- **Device Name:** Mri Disposable Kit
- **Regulation:** [21 CFR 892.1000](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1000)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

## Classification Rationale

Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device 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 magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device 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/OIM](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OIM)

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