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510(k) K151233

Monaco by Impac Medical Systems, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2015
Date Received
May 8, 2015
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 Impac Medical Systems, Inc.

  • K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (September 5, 2014)
  • K132971 — MONACO (November 20, 2013)
  • K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (December 12, 2012)
  • K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (February 28, 2012)
  • K043412 — MODIFICATION TO: VIEWSTATION (December 20, 2004)
  • K013531 — QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 (November 7, 2001)
  • K011694 — VIEWSTATION (August 29, 2001)
  • K991133 — MLC FIT (March 27, 2000)
  • K981313 — SEQUENCER (July 9, 1998)
  • K962335 — MLC FIT (February 6, 1997)

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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)
  • K242748 — Oncospace (April 11, 2025)