# K190178: Monaco RTP System

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Inc.
- Decided: Mar 29, 2019 after 56 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: 16 generations back to K913770 (1991). 213 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183037: Monaco RTP System, Elekta, Inc. (2018) Summary page 5.

## Most influential descendants
- K202789: Monaco Rtp System (2021), 3 descendants of its own
- K213787: Monaco RTP System (2022), 2 descendants of its own
- K223233: Monaco RTP System (2023), 1 descendant of its own
- K252002: Monaco RTP System (6.3) (2026), 0 descendants of its own

## Recalls of this device
- Sep 14, 2021 · Class II · Z-2563-2021: Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
- Jul 26, 2021 · Class II · Z-2406-2021: If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
- Nov 22, 2019 · Class II · Z-0670-2020: Monaco is using the incorrect energy when optimizing and calculating dose.
- Sep 4, 2019 · Class II · Z-2561-2019: It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
- Aug 23, 2019 · Class II · Z-2409-2019: Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

## 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/K190178
Methodology: https://510kreport.com/methodology