1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K103506
Device Name 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
Applicant
IMRIS, INC.
16809 briardale road
rockville, 
MD 
20855

Applicant Contact thomas m taskeris
Correspondent
IMRIS, INC.
16809 briardale road
rockville, 
MD 
20855

Correspodent Contact thomas m taskeris
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/29/2010
Decision Date 02/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No