Who is the manufacturer of HRH-63 HEAD ARRAY COIL?

Mri Devices Corp. submitted the Traditional clearance for HRH-63 HEAD ARRAY COIL (K002774).

What is the FDA product code for HRH-63 HEAD ARRAY COIL?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for HRH-63 HEAD ARRAY COIL?

510(k) clearance (submission type: Traditional).

HRH-63 HEAD ARRAY COIL

K002774 · Mri Devices Corp. · MOS · Nov 16, 2000 · Radiology

Device Facts

Record ID	K002774
Device Name	HRH-63 HEAD ARRAY COIL
Applicant	Mri Devices Corp.
Product Code	MOS · Radiology
Decision Date	Nov 16, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Regulatory Classification

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).

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.