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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 K060779
Device Name ADVANCE VESSEL ANALYSIS II
Applicant
GE Healthcare
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/22/2006
Decision Date 04/05/2006
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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