GE VEO RECONSTRUCTION OPTION


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K103489
Device Name GE VEO RECONSTRUCTION OPTION
Applicant
GENERAL ELECTRIC CO.
3000 n. grandview blvd.
w1140
waukesha, 
WI 
53188

Applicant Contact andrew j menden
Correspondent
GENERAL ELECTRIC CO.
3000 n. grandview blvd.
w1140
waukesha, 
WI 
53188

Correspodent Contact andrew j menden
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 11/26/2010
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No