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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 K140823
Device Name PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER
Applicant
VARIAN MEDICAL SYSTEMS, INC.
2101 4th Ave Ste 100
SEATTLE,  WA  98121
Applicant Contact LISA LEVINE
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
2101 4th Ave Ste 100
SEATTLE,  WA  98121
Correspondent Contact LISA LEVINE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/01/2014
Decision Date 06/27/2014
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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