MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K110591
Device Name MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
Applicant
MR INSTRUMENTS, INC.
5610 rowland road
suite 145
minnetonka, 
MN 
55343

Applicant Contact joshua j holwell
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 03/02/2011
Decision Date 03/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No