# K020971: DCM 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Mds Nordion AB
- Decided: Jun 6, 2002 after 72 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: 5 generations back to K884261 (1989). 17 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010682: Helax-TMS V 5.1 Radiation Therapy Treatment Planning System, Mds Nordion (2001)
- K011246: DCM 1.0, Mds Nordion (2001) Summary page 1.

## Most influential descendants
- K130617: Raystation (2013), 21 descendants of its own
- K140187: Ray Station (2014), 19 descendants of its own
- K141860: Raystation (2014), 17 descendants of its own
- K160093: RayStation (2016), 16 descendants of its own
- K170355: RayStation 6 (2017), 15 descendants of its own

## Indications for use
DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in oncology clinic. Based on quality assured radiation therapy input data Dose Calculation Module is used to plan radiation treatment with: Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 to 25 MeV Cobalt-60 units DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.

Source page: https://510kreport.com/device/K020971
Methodology: https://510kreport.com/methodology