GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K081105
Device Name GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
Applicant
GE HEALTHCARE
3000 n. grandview blvd.
waukesha, 
WI 
53188

Applicant Contact andrew menden
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 04/18/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls