21 CFR 892.1000 — System, Nuclear Magnetic Resonance Imaging
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1000
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 1098 | 3rd Party |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 2 | 10 | 3rd Party |
| MOS | Coil, Magnetic Resonance, Specialty | 2 | 487 | 3rd Party |
| OIM | Mri Disposable Kit | 2 | 0 |
Special Controls
LNH — System, Nuclear Magnetic Resonance Imaging
*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.
eCFR
LNI — System, Nuclear Magnetic Resonance Spectroscopic
*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.
eCFR
MOS — Coil, Magnetic Resonance, Specialty
*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.
eCFR
OIM — Mri Disposable Kit
*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.
eCFR
