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510(k) K233236

Radiance V5 by Gmv Soluciones Globales Internet S.A.U. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2024
Date Received
September 28, 2023
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

Other clearances by Gmv Soluciones Globales Internet S.A.U.

  • K171885 — Radiance V4 (July 25, 2017)
  • K153368 — Radiance V3 (February 16, 2016)
  • K133655 — RADIANCE V2 (January 31, 2014)

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