SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K992135
Device Name SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
Applicant
GE MEDICAL SYSTEMS, INC.
p.o. box 414
milwaukee, 
WI 
53201

Applicant Contact larry a kroger
Correspondent
GE MEDICAL SYSTEMS, INC.
p.o. box 414
milwaukee, 
WI 
53201

Correspodent Contact larry a kroger
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 06/24/1999
Decision Date 09/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized