ECHELON RAPID CARDIAC COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K110120
Device Name ECHELON RAPID CARDIAC COIL
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 01/18/2011
Decision Date 02/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

Yes