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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 K071360
Device Name OPTICAL GUIDANCE PLATFORM
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304
Applicant Contact VY TRAN
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/15/2007
Decision Date 06/08/2007
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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