CT COLONOGRAPHY


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K023943
Device Name CT COLONOGRAPHY
Original Applicant
GE MEDICAL SYSTEMS, INC.
p.o. box 414
milwaukee, 
WI 
53201

Original Contact larry a kroger
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 11/26/2002
Decision Date 05/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No