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Code · CFR · Title 21 — Food and Drugs · Part 892 — Radiology Devices · § 892.1000

§ 892.1000. Magnetic resonance diagnostic device.

131 words·~1 min read·/us/cfr/t21/s§ 892.1000·

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(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 of this chapter subject to the limitations in § 892.9. [53 FR 5078, Feb. 1, 1989, as amended at 84 FR 71818, Dec. 30, 2019]
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§ 892.1000
Magnetic resonance diagnostic device.
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