510(k) · Cleared
ClearedTreatment Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Mar 7, 1996 as substantially equivalent to K914926 (Scanditronix, Inc., 1992) after a 232-day review. Its family tree reaches back 1 generation to 1992. 27 later devices descend from it.
- Decided
- Mar 7, 1996
- Review
- 232 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914926 (1992). 27 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK914926 Scandiplan - Version 338Scanditronix, Inc. · 1992
- This deviceK953391 Treatment Management SystemSiemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
- Descendant · cites it directly · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
- Descendant · 2 generations on · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
- Descendant · 3 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 4 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 · cites it directly23descendants
- K020971DCM 2.0Mds Nordion AB · 2002 · 2 generations on22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 3 generations on21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914926 | Scandiplan - Version 338 | Scanditronix, Inc. | 1992 | — |
| 0 (this device) | K953391 | Treatment Management System | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | 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 | — |
| +2 | K020971 | DCM 2.0 | Mds Nordion AB | 2002 | — |
| +3 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +4 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 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 |
|---|---|---|---|
| * | K914926 | Scandiplan - Version 338 Our OCR of the scanned summary read K814926, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SCANDIPLAN 3-Dimensional Radiation Therapy Treatment Planning System”. | 1992 |
What descends from it? (27)
See all 273 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?
- Its one ancestor has no recall.
- Of its descendants, K993766 (Helax AB, 1999) has gone furthest, with 24 descendants of its own.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
TMS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 4 to 50MV, as well as Cobalt-60, and electron energies from 4 to 50 MeV. TMS will plan the 3D radiotherapy treatment approaches of combined modality plans, asymmetric and noncoplanar fields; total body irradiation (TBI); multi-leaf collimators (MLC); motorized and dynamic wedges; customized blocking; compensating filters (CF); and bolus.
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/K953391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953391: Treatment Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953391
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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