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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 K934572
Device Name UNITONE
Applicant
Scitex Corporation , Ltd.
33 Ravuski
Raanana,  IL ?
Applicant Contact ARNOLD C TARAGIN
Correspondent
Scitex Corporation , Ltd.
33 Ravuski
Raanana,  IL ?
Correspondent Contact ARNOLD C TARAGIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/21/1993
Decision Date 12/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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