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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 K100115
Device Name XVI R4.5
Applicant
ELEKTA LTD.
FLEMING WAY
CRAWLEY,  GB RH10 9RR
Applicant Contact ANDREW HEDGES
Correspondent
ELEKTA LTD.
FLEMING WAY
CRAWLEY,  GB RH10 9RR
Correspondent Contact ANDREW HEDGES
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/15/2010
Decision Date 03/10/2010
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
Recalls CDRH Recalls
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