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510(k) K232479

ART-Plan by Therapanacea — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
August 16, 2023
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 Therapanacea

  • K253091 — ART-Plan+ (v3.1.0) (December 23, 2025)
  • K242822 — ART-Plan+ (v.3.0.0) (February 25, 2025)
  • K234068 — ART-Plan (v.2.2.0) (April 22, 2024)
  • K230023 — ART-Plan (April 19, 2023)
  • K220813 — ART-PLAN (June 17, 2022)
  • K202700 — ART-Plan (January 14, 2021)

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)