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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 K023936
Device Name MODIFICATION TO MEDIPRIME
Applicant
Algotec Systems, Ltd.
P.O. Box 6718
Efrat,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
Algotec Systems, Ltd.
P.O. Box 6718
Efrat,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/26/2002
Decision Date 12/20/2002
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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