510(k) · Cleared
ClearedDCM 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mds Nordion · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 23, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- May 23, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 3 citing it directly.
- This deviceK011246 DCM 1.0Mds Nordion · 2001
- Descendant · cites it directly · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
- Descendant · 2 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 4 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 5 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K020971DCM 2.0Mds Nordion AB · 2002 · cites it directly22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 2 generations on21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 3 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 4 generations on17descendants
- K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011246 | DCM 1.0 | Mds Nordion | 2001 | — |
| +1 | K020971 | DCM 2.0 | Mds Nordion AB | 2002 | — |
| +2 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +3 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +4 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| +5 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 263 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K020971 (Mds Nordion AB, 2002) has gone furthest, with 22 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 | — |
https://510kreport.com/device/K011246 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011246: DCM 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011246
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026