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510(k) K220141

RayStation 11B by RaySearch Laboratories AB (PUBL) — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2022
Date Received
January 18, 2022
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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