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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 K150706
Device Name VitalBeam
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1129
Applicant Contact PETER J. CORONADO
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1129
Correspondent Contact PETER J. CORONADO
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/18/2015
Decision Date 05/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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