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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 K112613
Device Name INTEGRITY(TM)
Applicant
Elekta Limited
LINAC HOUSE
CRAWLEY, WEST SUSSEX,  GB RH10 9RR
Applicant Contact ANDREW HEDGES
Correspondent
Elekta Limited
LINAC HOUSE
CRAWLEY, WEST SUSSEX,  GB RH10 9RR
Correspondent Contact ANDREW HEDGES
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/07/2011
Decision Date 12/16/2011
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
Recalls CDRH Recalls
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