# K132971: Monaco

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Nov 20, 2013 after 58 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K914698 (1992). 51 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110730: Monaco RTP System, Computerized Medical Systems, Inc. (2011) Summary page 3.
- 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.
- K121448: Oncentra, Oncentra External Beam, Oncentra Brachy, Elekta Inc. D/B/A Nucletron Corporation (2012) Summary page 2.

## Most influential descendants
- 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
- K213787: Monaco RTP System (2022), 2 descendants of its own

## Recalls of this device
- Dec 21, 2016 · Class II · Z-1009-2017: Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
- Nov 17, 2016 · Class II · Z-0668-2017: Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
- Dec 19, 2014 · Class II · Z-1237-2015: Incorrect CT to ED when using the Monaco Image Statistics Tool.
- Aug 18, 2014 · Class II · Z-2581-2014: Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported

## 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 and electron 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/K132971
Methodology: https://510kreport.com/methodology