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510(k) K250963

PlanOne 1 by Cosylab Jsc, Control System Laboratory — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2025
Date Received
March 31, 2025
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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