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510(k) K210645

RayStation 10.1 by RaySearch Laboratories AB (PUBL) — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2021
Date Received
March 3, 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

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  • K211867 — RayStation 11.0 (September 8, 2021)
  • K200569 — RayStation (September 24, 2020)
  • K200487 — RayCare 3.1 (June 10, 2020)
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  • K190387 — RayStation (June 19, 2019)

Other clearances for product code MUJ

  • K260308 — TrueFit Bolus (February 19, 2026)
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  • K252109 — RayStation (2024A SP3) (December 22, 2025)
  • K252863 — ClearCalc Model RADCA V2.6 (December 19, 2025)
  • K250963 — PlanOne 1 (November 20, 2025)
  • K250064 — Dose+ (1.0) (September 4, 2025)
  • K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (June 17, 2025)
  • K242992 — RayCare (2024A SP1) (April 17, 2025)
  • K242748 — Oncospace (April 11, 2025)