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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K033339
Device Name ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1038
Applicant Contact VY TRAN
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1038
Correspondent Contact VY TRAN
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received10/17/2003
Decision Date 12/30/2003
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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