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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K191580
Device Name BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Peter J. Coronado
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Peter J. Coronado
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received06/14/2019
Decision Date 07/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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