510(k) · Cleared
ClearedCommissioning Data Management System (CDMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D3 Radiation Planning · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Nov 10, 2008 as substantially equivalent to K010464 (Lifeline Software, Inc., 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Nov 10, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010464 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010464 Radcalc, Model V.4.0Lifeline Software, Inc. · 2001
- 1 generation backK031975 ImsureProdigm, Inc. · 2003
- This deviceK082606 Commissioning Data Management System (CDMS)D3 Radiation Planning · 2008
- Descendant · cites it directly · 0 of its ownK090182 Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010464 | Radcalc, Model V.4.0 | Lifeline Software, Inc. | 2001 | — |
| −1 | K031975 | Imsure | Prodigm, Inc. | 2003 | — |
| 0 (this device) | K082606 | Commissioning Data Management System (CDMS) | D3 Radiation Planning | 2008 | — |
| +1 | K090182 | Module Integrated Radiotherapy System (Mirs) | Nuclemed S.A. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K010464 | Radcalc, Model V.4.0Summary page 1…ticle radiation therapy system, §892.5050. (3) Identification of predicate Marketed device: K010464 RadCalc V4.0. K031975 IMSure. (4) Device Description:… | 2001 |
| * | K031975 | ImsureSummary page 1…§892.5050. (3) Identification of predicate Marketed device: K010464 RadCalc V4.0. K031975 IMSure. (4) Device Description: CDMS is a software program designed to record radiation… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090182 | Module Integrated Radiotherapy System (Mirs) | 2009 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090182 (Nuclemed S.A., 2009) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K010464.
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. 2008, this device’s year, is highlighted.
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?
CDMS is a Microsoft Windows based software application designed to record and manage physics data acquired during acceptance testing, commissioning and calibration of radiation therapy treatment devices. In addition, CDMS uses the same physics data to allow users to perform MU calculations based on treatment field parameters that are either imported from the treatment planning system or entered manually. CDMS is also used to manage linac calibration using standard protocols.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082606: Commissioning Data Management System (CDMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082606
Report an extraction error
Are you the manufacturer?
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