# K082221: Raydose

- Pathway: 510(k) (Traditional)
- Applicant: Raysearch Laboratories AB
- Decided: Oct 22, 2008 after 77 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: 6 generations back to K914698 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011246: DCM 1.0, Mds Nordion (2001)
- K041577: PINNACLE3 Radiation Therapy Planning System, Adac Laboratories (2004) Summary page 1.

## Indications for use
RayDose is software that computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts. Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities: o Symmetric and asymmetric rectangular fields o Multileaf collimated fields o Coplanar and non-coplanar fields o Intensity modulated fields using Step-and-shoot technique o Intensity modulated fields using Sliding Window technique

Source page: https://510kreport.com/device/K082221
Methodology: https://510kreport.com/methodology