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510(k) K220582

ClearCalc Model RADCA V2 by Radformation, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2022
Date Received
March 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

Other clearances by Radformation, Inc.

  • K252988 — ChartCheck (RADCH V1.6) (January 5, 2026)
  • K252863 — ClearCalc Model RADCA V2.6 (December 19, 2025)
  • K242729 — AutoContour (Model RADAC V4) (December 9, 2024)
  • K230685 — AutoContour Model RADAC V3 (April 14, 2023)
  • K220598 — AutoContour Model RADAC V2 (August 24, 2022)
  • K220583 — ClearCheck Model RADCC V2 (August 23, 2022)
  • K200323 — AutoContour (October 30, 2020)
  • K201119 — ChartCheck (June 26, 2020)
  • K193640 — ClearCalc (April 9, 2020)
  • K171352 — EZFluence (December 1, 2017)

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)