1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K110610
Device Name 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
Applicant
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha, 
WI 
53188

Applicant Contact michelle scheidt
Correspondent
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha, 
WI 
53188

Correspodent Contact michelle scheidt
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 03/03/2011
Decision Date 04/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No