Monaco Rtp System, Vmat Option

• • Terminated Z-2598-2011 FDA Unclassified (pre-2012) ·initiated 13 Jan 2011

  Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.

• • Terminated Z-2561-2011 FDA Unclassified (pre-2012) ·initiated 13 Jan 2011

  Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.

• • Terminated Z-2569-2011 FDA Unclassified (pre-2012) ·initiated 27 Oct 2010

  Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.

• • Terminated Z-2564-2011 FDA Unclassified (pre-2012) ·initiated 31 May 2010

  Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans.

• • Terminated Z-2560-2011 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008

  Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though Monte Carlo was selected. Other than specific output to the console window, there will be no other in

510(k) Number

K091179 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Focus

  Class II

  FDA 510(k) K002147 Active Cleared 13 Oct 2000

• Monaco Rtp System

  Class II

  FDA 510(k) K110730 Active Cleared 24 Jun 2011

• Enhanced Compensating Filter

  Class II

  FDA 510(k) K000137 Active Cleared 17 Apr 2000

• Focus Rtp System

  Class II

  FDA 510(k) K973936 Active Cleared 1 Jun 1998

• I-Beam

  Class II

  FDA 510(k) K032100 Active Cleared 2 Oct 2003

• Record and Verify Mevatron Adapter

  Class II

  FDA 510(k) K913674 Active Cleared 22 Nov 1991

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• What is the primary function of the Monaco RTP System, VMAT Option?

  This device is a radiation therapy treatment planning system. It is designed to assist medical professionals in creating optimized treatment plans for cancer patients by increasing the precision of tumor targeting while simultaneously sparing surrounding healthy tissue.

• What is the regulatory status of this system?

  The Monaco RTP System, VMAT Option has received FDA 510(k) clearance. It is classified as a Class 2 medical device under regulation number 892.5050 and has been determined to be a substantially equivalent system for use in clinical radiation therapy environments.

• Which medical specialty is this device associated with?

  The system is categorized under the Radiology medical specialty. It is intended for use by clinical professionals within radiation therapy environments to support the planning and delivery of treatment.