510(k) K211867

RayStation 11.0 by RaySearch Laboratories AB (PUBL) — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2021
Date Received
June 16, 2021
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