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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 K093527
Device Name ARIA RADIATION ONCOLOGY WITH MIRS
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way
M/S E-110
Palo Alto,  CA  94304
Applicant Contact VY TRAN
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
M/S E-110
Palo Alto,  CA  94304
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received11/16/2009
Decision Date 12/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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