510(k) · Cleared
ClearedLeksell Gammaplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instrument AB · IWB System, Radiation Therapy, Radionuclide
Cleared on Jul 5, 2006 as substantially equivalent to K051022 (Elekta Instrument AB, 2005) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1992. 9 later devices descend from it.
- Decided
- Jul 5, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914808 (1992). 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914808 Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992
- 3 generations backK973441 Leksell GammaplanPatterson Consulting Group, Inc. · 1998 · Recalled
- 2 generations backK042269 Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004
- 1 generation backK051022 GammaplanElekta Instrument AB · 2005
- This deviceK061540 Leksell GammaplanElekta Instrument AB · 2006
- Descendant · cites it directly · 6 of its ownK090972 Leksell GammaplanElekta Instrument AB · 2009
- Descendant · 2 generations on · 5 of its ownK103093 Leksell GammaplanElekta Instrument AB · 2010 · Recalled
- Descendant · 3 generations on · 4 of its ownK151666 Leksell GammaPlanElekta Instrument AB · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK173791 Leksell GammaPlanElekta Instrument AB · 2018 · Recalled
- Descendant · 5 generations on · 1 of its ownK193459 Panther StereotacticProwess, Inc. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K090972Leksell GammaplanElekta Instrument AB · 2009 · cites it directly6descendants
- K103093Leksell GammaplanElekta Instrument AB · 2010 · 2 generations on5descendants
- K151666Leksell GammaPlanElekta Instrument AB · 2015 · 3 generations on4descendants
- K173791Leksell GammaPlanElekta Instrument AB · 2018 · 4 generations on3descendants
- K193459Panther StereotacticProwess, Inc. · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914808 | Leksell Gammaplan (LGP) | Elekta Instruments, Inc. | 1992 | — |
| −3 | K973441 | Leksell Gammaplan | Patterson Consulting Group, Inc. | 1998 | 4 |
| −2 | K042269 | Leksell Gammaplan 4C with Multiview | Elekta Instrument AB | 2004 | — |
| −1 | K051022 | Gammaplan | Elekta Instrument AB | 2005 | — |
| 0 (this device) | K061540 | Leksell Gammaplan | Elekta Instrument AB | 2006 | — |
| +1 | K090972 | Leksell Gammaplan | Elekta Instrument AB | 2009 | — |
| +2 | K103093 | Leksell Gammaplan | Elekta Instrument AB | 2010 | 1 |
| +3 | K151666 | Leksell GammaPlan | Elekta Instrument AB | 2015 | 1 |
| +4 | K173791 | Leksell GammaPlan | Elekta Instrument AB | 2018 | 2 |
| +5 | K193459 | Panther Stereotactic | Prowess, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 IWB? 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 IWB device
- #1 K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell…score 11.2 · 13 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.
What descends from it? (9)
2 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 14 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K090972 (Elekta Instrument AB, 2009) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K051022.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IWB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IWB
57in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IWB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWB
3in 2025
MAUDE reports naming product code IWB, 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 | 1 | — | 3 | 8 |
| 2008 | 0 | — | 3 | 15 |
| 2009 | 1 | — | 1 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 3 | 170 | 1 | 8 |
| 2015 | 3 | 79 | 0 | 5 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 57 | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061540: Leksell Gammaplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061540
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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