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510(k) K153368

Radiance V3 by Gmv Soluciones Globales Internet S.A.U. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2016
Date Received
November 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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