510(k) · Cleared
ClearedHelax-TMS V 5.1 Radiation Therapy Treatment Planning System
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 Jun 5, 2001 as substantially equivalent to K993766 (Helax AB, 1999) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1989. 23 later devices descend from it.
- Decided
- Jun 5, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K884261 (1989). 15 ancestors in all, the oldest K802809 (1981). 23 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 3 generations backK940663 Peacock PlanNomos Corp. · 1996
- 2 generations backK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
- 1 generation backK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
- This deviceK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds 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 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · 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 |
|---|---|---|---|---|---|
| −4 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −3 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K010682 | Helax-TMS V 5.1 Radiation Therapy Treatment Planning System | 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 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (4)
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 |
|---|---|---|---|
| * | K993766 | Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemSummary page 1…2.5050) 1.5 Common or Usual Name: Radiation Therapy Treatment Planning System 1.6 Legally Marketed Predicate Device: Helax-TMS v 5.0 (K993766), Helax-TMS v 3.0 (K962892) and Helax-TMS v 2.10 (K953391), Varian Proton Vision 7.0 (K002312) 1.7 Descri… | 1999 |
| * | K962892 | Helax TMS Brachytherapy, Version 3.0Summary page 1…r Usual Name: Radiation Therapy Treatment Planning System 1.6 Legally Marketed Predicate Device: Helax-TMS v 5.0 (K993766), Helax-TMS v 3.0 (K962892) and Helax-TMS v 2.10 (K953391), Varian Proton Vision 7.0 (K002312) 1.7 Description of Helax-TMS Proton F… | 1996 |
| * | K953391 | Treatment Management SystemSummary page 1…apy Treatment Planning System 1.6 Legally Marketed Predicate Device: Helax-TMS v 5.0 (K993766), Helax-TMS v 3.0 (K962892) and Helax-TMS v 2.10 (K953391), Varian Proton Vision 7.0 (K002312) 1.7 Description of Helax-TMS Proton Functionality: Helax TMS is a 3… | 1996 |
| * | K002312 | Proton Vision 7.0Summary page 1…lly Marketed Predicate Device: Helax-TMS v 5.0 (K993766), Helax-TMS v 3.0 (K962892) and Helax-TMS v 2.10 (K953391), Varian Proton Vision 7.0 (K002312) 1.7 Description of Helax-TMS Proton Functionality: Helax TMS is a 3D Radiotherapy Treatment Planning (RTP) syste… | 2000 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020971 | DCM 2.0 | 2002 | 22 |
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 12 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 15 ancestors has a recall.
- 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 | — |
What is it indicated for?
Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or brachytherapy treatment in the oncology clinic. The system is designed to lead the user through a logical flow planning process. Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with: (i) Linear accelerators with X-ray energies from 4 to 50MV and electron…
Read the full statement (167 words)
Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning,
but not treatment, of patients undergoing external beam or brachytherapy treatment in the
oncology clinic. The system is designed to lead the user through a logical flow planning
process.
Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation
treatments with:
(i) Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4
to 50MeV, proton energies from 1 to 275 MeV as well as cobalt-60 units. Helax-TMS
will plan 3D radiotherapy treatment approaches of combined modality plans,
asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators;
motorised and dynamic wedges; customised blocking; compensating filters; and
bolus.
(ii) Brachytherapy units for patients undergoing interstitial or intracavitary treatment in
the Oncology clinic.
Export capabilities exists as part of Helax-TMS to verify beam and patient data, dose
planning results, and provide on-line information to block-cutting devices and milling
machines, multi-leaf collimator control units, as well as record and verify systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K010682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010682: Helax-TMS V 5.1 Radiation Therapy Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010682
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026