IDEAL IQ SOFTWARE OPTION


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K103411
Device Name IDEAL IQ SOFTWARE OPTION
Applicant
GE MEDICAL SYSTEMS
3200 n grandview blvd
w-827
waukesha, 
WI 
53188

Applicant Contact tracey fox
Correspondent
GE MEDICAL SYSTEMS
3200 n grandview blvd
w-827
waukesha, 
WI 
53188

Correspodent Contact tracey fox
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 11/22/2010
Decision Date 03/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No