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510(k) K222312

RayStation 12A by RaySearch Laboratories AB (PUBL) — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2023
Date Received
August 1, 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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