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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K023100
Device Name ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
Applicant
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact LISA LEE MICHELS
Correspondent
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact LISA LEE MICHELS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/18/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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