SV BRAIN ARRAY, SIEMENS 3T


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K111802
Device Name SV BRAIN ARRAY, SIEMENS 3T
Applicant
MRI INTERVENTIONS, INC.
5 musick
irvine, 
CA 
92618

Applicant Contact e.f. waddell
Correspondent
MRI INTERVENTIONS, INC.
5 musick
irvine, 
CA 
92618

Correspodent Contact e.f. waddell
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 06/27/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No