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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 K111106
Device Name TRUEBEAM
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304
Applicant Contact VY TRAN
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/20/2011
Decision Date 08/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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