OPTIMA CT660


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K110227
Device Name OPTIMA CT660
Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, 
WI 
53188

Applicant Contact tracey ortiz
Correspondent
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, 
WI 
53188

Correspodent Contact tracey ortiz
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 01/25/2011
Decision Date 07/20/2011
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