CARDIQ FUNCTION XPRESS


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K073153
Device Name CARDIQ FUNCTION XPRESS
Applicant
GE MEDICAL SYSTEMS SCS
283 rue de la miniere bp 34
buc cedex, 

FR

78533

Regulation Number 892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received 11/08/2007
Decision Date 02/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No