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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K964485
Device Name PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
Applicant
Eliav , Ltd.
Pob 6718
Efrat,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
Eliav , Ltd.
Pob 6718
Efrat,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
IYG   JAE  
Date Received11/08/1996
Decision Date 02/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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