510(k) · Cleared
ClearedCadplan Helios Option 6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Aug 9, 1999 as substantially equivalent to K940663 (Nomos Corp., 1996) after a 231-day review. Its family tree reaches back 2 generations to 1989. 27 later devices descend from it.
- Decided
- Aug 9, 1999
- Review
- 231 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K884261 (1989). 4 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 1 generation backK940663 Peacock PlanNomos Corp. · 1996
- This deviceK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
- Descendant · cites it directly · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
- Descendant · 2 generations on · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
- Descendant · 3 generations on · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
- Descendant · 4 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 5 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999 · cites it directly24descendants
- K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001 · 2 generations on23descendants
- K020971DCM 2.0Mds Nordion AB · 2002 · 3 generations on22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 4 generations on21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −1 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| 0 (this device) | K984532 | Cadplan Helios Option 6.0 | Varian Medical Systems, Inc. | 1999 | — |
| +1 | K993766 | Helax-TMS V 5.0 Radiation Therapy Treatment Planning System | Helax AB | 1999 | — |
| +2 | K010682 | Helax-TMS V 5.1 Radiation Therapy Treatment Planning System | Mds Nordion | 2001 | — |
| +3 | K020971 | DCM 2.0 | Mds Nordion AB | 2002 | — |
| +4 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +5 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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), 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? (1)
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 |
|---|---|---|---|
| * | K940663 | Peacock PlanSummary page 1…4-4830 E-Mail [email protected] Device Name: CadPlan Helios Option 6.0 Classification Name: Accelerator, Linear, Medical Predicate Device: Peacock Plan CORVUS, K940663 Product Description: CadPlan Helios is an inverse planning tool for creating highly conformal plan using intensity- modulated f… | 1996 |
What descends from it? (27)
See all 272 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K993766 (Helax AB, 1999) has gone furthest, with 24 descendants of its own.
- 6 other devices also cite its predicate K940663.
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?
CadPlan is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices and x-ray energies from 4 to 50 MV, as well as Cobalt-60, and electron energies from 4 to 50 MeV, and to plan brachytherapy treatments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984532: Cadplan Helios Option 6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984532
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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