Who is the manufacturer of HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA?

Mri Devices Corp. submitted the Special clearance for HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA (K001713).

What is the FDA product code for HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA?

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

What is the regulatory pathway for HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA?

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

HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA

K001713 · Mri Devices Corp. · MOS · Jun 14, 2000 · Radiology

Device Facts

Record ID	K001713
Device Name	HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
Applicant	Mri Devices Corp.
Product Code	MOS · Radiology
Decision Date	Jun 14, 2000
Decision	SESE
Submission Type	Special
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.