510(k) K171885

Radiance V4 by Gmv Soluciones Globales Internet S.A.U. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2017
Date Received
June 26, 2017
Clearance Type
Special
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