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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K132183
Device Name DICOM VIDEO
Applicant
Bar Code Computer, Ltd.
6 Sireni
Haifa,  IL 32972
Applicant Contact DAN LAOR
Correspondent
Bar Code Computer, Ltd.
6 Sireni
Haifa,  IL 32972
Correspondent Contact DAN LAOR
Regulation Number892.2030
Classification Product Code
LMA  
Date Received07/15/2013
Decision Date 10/03/2013
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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