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510(k) K201119

ChartCheck by Radformation, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2020
Date Received
April 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
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)
  • K220582 — ClearCalc Model RADCA V2 (August 22, 2022)
  • K200323 — AutoContour (October 30, 2020)
  • K193640 — ClearCalc (April 9, 2020)
  • K171352 — EZFluence (December 1, 2017)

Other clearances for product code IYE

  • K252977 — Halcyon, Ethos Radiotherapy System (5.0) (January 21, 2026)
  • K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin (January 15, 2026)
  • K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (January 14, 2026)
  • K252988 — ChartCheck (RADCH V1.6) (January 5, 2026)
  • K252919 — IDENTIFY (5.0) (December 16, 2025)
  • K250392 — ZAP-X Radiosurgery System (ZAP-X) (November 3, 2025)
  • K250696 — AccuCheck (October 24, 2025)
  • K250911 — MOSkin Radiation Measurement System (October 17, 2025)
  • K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam (October 7, 2025)
  • K252174 — AquaCast Mask (September 3, 2025)