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510(k) K230557

Eclipse Treatment Planning System (v18.0) by Varian Medical Systems, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2023
Date Received
February 28, 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

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Other clearances for product code MUJ

  • K252304 — syngo.via RT Image Suite VC10 (March 18, 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)