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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 K170570
Device Name Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Lisa Levine
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Lisa Levine
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/27/2017
Decision Date 04/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT01396551
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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