# K110730: Monaco RTP System

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Jun 24, 2011 after 100 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K914698 (1992). 46 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091179: Monaco RTP System, Vmat Option, Computerized Medical Systems, Inc. (2009) Summary page 2.
- K080601: Ergo++ Version 1.7, 3D Line Medical Systems S.R.L. (2008) Summary page 2.
- K102011: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2010) Summary page 2.

## Most influential descendants
- 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
- K202789: Monaco Rtp System (2021), 3 descendants of its own

## Recalls of this device
- Aug 18, 2016 · Class II · Z-2712-2016: In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours 
- Jul 2, 2013 · Class II · Z-2276-2013: Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
- May 22, 2013 · Class II · Z-2277-2013: Patient needs to be positioned as indicated by the treatment plan.
- Feb 11, 2013 · Class II · Z-0841-2013: The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
- Jun 21, 2012 · Class II · Z-2007-2012: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
- Mar 5, 2012 · Not classified · Z-1365-2012: An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.

## Indications for use
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: * contouring * image manipulation * simulation * image fusion * plan optimization * QA and plan review

Source page: https://510kreport.com/device/K110730
Methodology: https://510kreport.com/methodology