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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 K102765
Device Name PRONEX
Applicant
Direx Systems Corp.
437 Tpke. St.
Canton,  MA  02021
Applicant Contact LARISA GERSHTEIN
Correspondent
Direx Systems Corp.
437 Tpke. St.
Canton,  MA  02021
Correspondent Contact LARISA GERSHTEIN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/24/2010
Decision Date 12/07/2010
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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