GE 0.2T SIGNA PROFILE/I MR SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K033168
Device Name GE 0.2T SIGNA PROFILE/I MR SYSTEM
Applicant
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee, 
WI 
53201

Applicant Contact larry a kroger
Correspondent
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee, 
WI 
53201

Correspodent Contact larry a kroger
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 09/30/2003
Decision Date 10/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls