---
kind: "section"
citation: "21 C.F.R. § 892.1000"
title: "21"
number: "892.1000"
heading: "Magnetic resonance diagnostic device."
url: "https://uscodex.org/cfr/21/892.1000"
---

# §892.1000. Magnetic resonance diagnostic device.

- (a) **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).
- (b) **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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 892.9](/cfr/21/892.9.md).

## Notes

### Amendments

[53 FR 5078, Feb. 1, 1989, as amended at 84 FR 71818, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

### Amendments

[53 FR 5078, Feb. 1, 1989, as amended at 84 FR 71818, Dec. 30, 2019]