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510(k) K183037

Monaco RTP System by Elekta, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2018
Date Received
November 1, 2018
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 Elekta, Inc.

  • K190178 — Monaco RTP System (March 29, 2019)
  • K183034 — MOSAIQ Oncology Information System (December 4, 2018)
  • K141855 — CLARITY (October 8, 2014)
  • K123808 — AGILITY (April 4, 2013)
  • K121663 — CLARITY (December 5, 2012)
  • K121328 — AGILITY (June 12, 2012)
  • K111332 — CLARITY OBP SYSTEM (January 30, 2012)
  • K102200 — INTEGRITY MODEL 1014284 (November 4, 2010)
  • K100115 — XVI R4.5 (March 10, 2010)
  • K082122 — MLCI2 (August 29, 2008)

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)