510(k) · Cleared
ClearedDCM 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mds Nordion AB · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jun 6, 2002 as substantially equivalent to K010682 (Mds Nordion, 2001) and 1 other predicate after a 72-day review. Its family tree reaches back 5 generations to 1989. 22 later devices descend from it.
- Decided
- Jun 6, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K884261 (1989). 17 ancestors in all, the oldest K802809 (1981). 22 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 4 generations backK940663 Peacock PlanNomos Corp. · 1996
- 3 generations backK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
- 2 generations backK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
- 1 generation backK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
- This deviceK020971 DCM 2.0Mds Nordion AB · 2002
- Descendant · cites it directly · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 3 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 4 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- Descendant · 5 generations on · 15 of its ownK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K130617RaystationRaysearch Laboratories AB · 2013 · cites it directly21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 2 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 3 generations on17descendants
- K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 4 generations on16descendants
- K170355RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −4 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| −3 | K984532 | Cadplan Helios Option 6.0 | Varian Medical Systems, Inc. | 1999 | — |
| −2 | K993766 | Helax-TMS V 5.0 Radiation Therapy Treatment Planning System | Helax AB | 1999 | — |
| −1 | K010682 | Helax-TMS V 5.1 Radiation Therapy Treatment Planning System | Mds Nordion | 2001 | — |
| 0 (this device) | K020971 | DCM 2.0 | Mds Nordion AB | 2002 | — |
| +1 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +2 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +3 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| +4 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| +5 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010682 | Helax-TMS V 5.1 Radiation Therapy Treatment Planning System | 2001 |
| * | K011246 | DCM 1.0Summary page 1…5 Common or Usual Name: Radiation Therapy Treatment Planning System 1.6 Legally Marketed Predicate Device: Helax-TMS v 5.1 (KO10682) and DCM 1.0 (K011246) 1.7 Description of Dose Calculation Module (DCM): DCM 2.0 is intended for calculations of dose plans, the calc… | 2001 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130617 | Raystation | 2013 | 21 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K130617 (Raysearch Laboratories AB, 2013) has gone furthest, with 21 descendants of its own.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020971: DCM 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020971
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026