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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 K153368
Device Name Radiance V3
Applicant
Gmv Soluciones Globales Internet S.A.U.
Calle De Isaac Newton, 11
Madrid,  ES 28760
Applicant Contact CARLOS ILLANA
Correspondent
Qserve Group, Us, Inc.
P.O. Box 940
Charlestown,  NH  03603
Correspondent Contact PATSY TRISLER
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/23/2015
Decision Date 02/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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