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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 K041267
Device Name CARDIQ ANALYSIS III
Applicant
General Electric Medical Systems
3000 N. Grandview Blvd.
W-400
Waukesha,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
Tuv Rheinland of North America, Inc.
1279 Quarry Ln., Suite A
Pleasanton,  CA  94566
Correspondent Contact TAMAS BORSAI
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/12/2004
Decision Date 05/27/2004
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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