ATAMA SYSTEM


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K110411
Device Name ATAMA SYSTEM
Applicant
MONTERIS MEDICAL, INC.
100 – 78 innovation drive
winnipeg, 

CA

r3t 6c2

Applicant Contact jeff wilson
Correspondent
MONTERIS MEDICAL, INC.
100 – 78 innovation drive
winnipeg, 

CA

r3t 6c2

Correspodent Contact jeff wilson
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 02/14/2011
Decision Date 04/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No