LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K030420
Device Name LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
Applicant
GE MEDICAL SYSTEMS
3000 north grandview blvd.
waukesha, 
WI 
53188

Applicant Contact john w jaeckle
Correspondent
GE MEDICAL SYSTEMS
3000 north grandview blvd.
waukesha, 
WI 
53188

Correspodent Contact john w jaeckle
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 02/10/2003
Decision Date 03/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls