CARDIQ EXPRESS VERSION 2.0


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K073138
Device Name CARDIQ EXPRESS VERSION 2.0
Applicant
GE MEDICAL SYSTEMS
3000 north grandview blvd.
waukesha, 
WI 
53188

Applicant Contact stephen slavens
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 11/07/2007
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