SIGNA 3.0T MAGNETIC RESONANCE SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K022397
Device Name SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
Original Applicant
GE MEDICAL SYSTEMS
p.o. 414
milwaukee, 
WI 
53201

Original Contact larry a kroger
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 07/23/2002
Decision Date 08/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No