# K091179: Monaco RTP System, Vmat Option

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Jul 16, 2009 after 84 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914698 (1992). 43 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071938: Monaco RTP System, Computerized Medical Systems, Inc. (2007) Summary page 2.
- K080601: Ergo++ Version 1.7, 3D Line Medical Systems S.R.L. (2008) Summary page 2.
- K073020: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2007) Summary page 2.

## Most influential descendants
- K110730: Monaco RTP System (2011), 8 descendants of its own
- K132971: Monaco (2013), 7 descendants of its own
- K151233: Monaco (2015), 6 descendants of its own
- K183037: Monaco RTP System (2018), 5 descendants of its own
- K190178: Monaco RTP System (2019), 4 descendants of its own

## Recalls of this device
- Jan 13, 2011 · Not classified · Z-2598-2011: Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.
- Jan 13, 2011 · Not classified · Z-2561-2011: 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.
- Oct 27, 2010 · Not classified · Z-2569-2011: 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.
- May 31, 2010 · Not classified · Z-2564-2011: 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.
- Jun 30, 2008 · Not classified · Z-2560-2011: 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 optimizat

## Indications for use
The Monaco system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.

Source page: https://510kreport.com/device/K091179
Methodology: https://510kreport.com/methodology