8 CHANNEL CARDIAC PHASED ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K022669
Device Name 8 CHANNEL CARDIAC PHASED ARRAY COIL
Original Applicant
GE MEDICAL SYSTEMS
p.o. box 414
milwaukee, 
WI 
53201

Original Contact larry kroger
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 08/12/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No