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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 K091132
Device Name 4D INTEGRATED TREATMENT CONSOLE
Applicant
VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
M/S E-110
PALO ALTO,  CA  94304 -1129
Applicant Contact VY TRAN
Correspondent
VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
M/S E-110
PALO ALTO,  CA  94304 -1129
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received04/20/2009
Decision Date 06/17/2009
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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