Title 21 Part 892 → Subpart B → §892.1000

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1000

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1000

e-CFR data is current as of June 18, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1000

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§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.

[53 FR 5078, Feb. 1, 1989]