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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K073138
Device Name CARDIQ EXPRESS VERSION 2.0
Applicant
GE Medical Systems
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact STEPHEN SLAVENS
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/07/2007
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
Predetermined Change
Control Plan Authorized		 No
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