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510(k) K240398

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 by RaySearch Laboratories AB (PUBL) — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
February 9, 2024
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

Other clearances by RaySearch Laboratories AB (PUBL)

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  • K222312 — RayStation 12A (March 29, 2023)
  • K220141 — RayStation 11B (April 15, 2022)
  • K211867 — RayStation 11.0 (September 8, 2021)
  • K210645 — RayStation 10.1 (June 29, 2021)
  • K200569 — RayStation (September 24, 2020)
  • K200487 — RayCare 3.1 (June 10, 2020)
  • K191384 — RayCare 2.3 (July 8, 2019)
  • K190387 — RayStation (June 19, 2019)

Other clearances for product code MUJ

  • K252002 — Monaco RTP System (6.3) (February 19, 2026)
  • K260308 — TrueFit Bolus (February 19, 2026)
  • K253091 — ART-Plan+ (v3.1.0) (December 23, 2025)
  • 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)