LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K023332
Device Name LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
Original Applicant
GE MEDICAL SYSTEMS
3000 north grandview blvd.
waukesha, 
WI 
53188

Original Contact larry a kroger
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 10/07/2002
Decision Date 10/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No