# K252002: Monaco RTP System (6.3)

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Feb 19, 2026 after 237 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K913770 (1991). 259 ancestors in all.
No later device cites it as a predicate yet.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223233: Monaco RTP System, Elekta Solutions AB (2023) Summary page 5.

## 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, electron, and proton 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/K252002
Methodology: https://510kreport.com/methodology