# K250963: PlanOne 1

- Pathway: 510(k) (Traditional)
- Applicant: Cosylab Jsc, Control System Laboratory
- Decided: Nov 20, 2025 after 234 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: 18 generations back to K010975 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230557: Eclipse Treatment Planning System (v18.0), Varian Medical Systems, Inc. (2023) Summary page 6.

## Indications for use
The PlanOne is a software system used to plan radiotherapy treatments for patients with malignant or benign diseases. PlanOne is used to plan external beam irradiation with photon and proton beams. The intended users of PlanOne shall be clinically qualified radiation therapy staff trained in using the system.

Source page: https://510kreport.com/device/K250963
Methodology: https://510kreport.com/methodology