ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K081198
Device Name ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg, 
OH 
44087

Applicant Contact doug thistlethwaite
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg, 
OH 
44087

Correspodent Contact doug thistlethwaite
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 04/28/2008
Decision Date 06/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No