ADVANTAGE WINDOWS X-RAY/MR FUSION


Device Classification Name

system, image processing, radiological

510(k) Number K022310
Device Name ADVANTAGE WINDOWS X-RAY/MR FUSION
Original Applicant
GE MEDICAL SYSTEMS, INC.
3000 n. grandview blvd.
waukesha, 
WI 
53188

Original Contact larry kroger
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/17/2002
Decision Date 08/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No