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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K984532
Device Name CADPLAN HELIOS OPTION 6.0
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3045 HANOVER ST.
PALO ALTO,  CA  94304 -1120
Applicant Contact LINDA S NASH
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3045 HANOVER ST.
PALO ALTO,  CA  94304 -1120
Correspondent Contact LINDA S NASH
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/21/1998
Decision Date 08/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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